Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-19 @ 12:44 AM
Study NCT ID:
NCT02607306
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613158', 'term': 'IDegLira'}, {'id': 'C571886', 'term': 'insulin degludec'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 (randomisation) to week 52 (end of treatment) and 7 days after end of treatment.', 'description': 'Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 153, 'seriousNumAtRisk': 275, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 137, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 158, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 42, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 166, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 161, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 155, 'numAffected': 94}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Autoimmune pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Benign neoplasm of bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastric cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Herpes zoster meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Large intestinal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pneumonia haemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Thrombotic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-1.80', 'spread': '0.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.52', 'pValueComment': 'p-value for non-inferiority of IDegLira vs IDeg is presented', 'groupDescription': 'The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.37', 'pValueComment': 'p-value for superiority of IDegLira vs Lira is presented', 'groupDescription': 'The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '-0.59', 'pValueComment': 'p-value for superiority of IDegLira vs IDeg is presented', 'groupDescription': 'The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in body weight after 52 weeks of treatment.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '467', 'groupId': 'OG000'}, {'value': '869', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.68', 'pValueComment': 'p-value for superiority of IDegLira vs IDeg is presented', 'groupDescription': 'The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-52', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-1.80', 'spread': '0.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.52', 'pValueComment': 'p-value for superiority of IDegLira vs IDeg is presented', 'groupDescription': 'The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.08', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-3.97', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '-2.62', 'spread': '1.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in FPG after 52 weeks', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '26.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Actual daily total insulin dose after 52 weeks of treatment.', 'unitOfMeasure': 'Insulin Units/Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated". Missing data were imputed using LOCF method. This endpoint evaluation is only applicable for subjects in IDegLira and IDeg arm.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in waist circumference after 52 weeks of treatment.', 'unitOfMeasure': 'Cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure (Systolic and Diastolic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '1.7', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '13.0', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '0.5', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '8.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Before breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.90', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '7.35', 'spread': '1.70', 'groupId': 'OG002'}]}]}, {'title': '90 minutes after start of breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.57', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '10.43', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '10.59', 'spread': '3.25', 'groupId': 'OG002'}]}]}, {'title': 'Before lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.01', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '6.72', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '6.87', 'spread': '2.07', 'groupId': 'OG002'}]}]}, {'title': '90 minutes after start of lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.85', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '11.12', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '10.59', 'spread': '3.38', 'groupId': 'OG002'}]}]}, {'title': 'Before dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.47', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '6.90', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '7.03', 'spread': '2.04', 'groupId': 'OG002'}]}]}, {'title': '90 minutes after start of dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.67', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '3.25', 'groupId': 'OG001'}, {'value': '10.14', 'spread': '3.03', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.27', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '9.49', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '8.73', 'spread': '2.58', 'groupId': 'OG002'}]}]}, {'title': 'At 4:00 a.m.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.12', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '7.27', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Before breakfast the following day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.77', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '7.13', 'spread': '1.68', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 52 weeks of the treatment', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Change in SMBG 9-point Profile - Mean of the 9-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.60', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-3.84', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '-3.46', 'spread': '2.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 52', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '-1.01', 'spread': '2.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 52', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '13.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '24.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '14.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '44.3', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '42.1', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '42.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Triglycerides as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '48.3', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '44.2', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '44.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Free Fatty Acids as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '60.8', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '59.3', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '49.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Fasting C-peptide as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '75.6', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '82.6', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '29.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Fasting Human Insulin as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '89.0', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '81.1', 'groupId': 'OG001'}, {'value': '1.52', 'spread': '66.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Fasting Glucagon as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '25.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Proinsulin as a Ratio to Baseline at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '231.5', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '188.8', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '85.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '873', 'groupId': 'OG000'}, {'value': '829', 'groupId': 'OG001'}, {'value': '885', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '4830', 'groupId': 'OG000'}, {'value': '6340', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-52 weeks', 'description': "Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:\n\n1. Severe hypoglycaemia\n2. Documented symptomatic hypoglycaemia\n3. Asymptomatic hypoglycaemia\n4. Probable symptomatic hypoglycaemia\n5. Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.", 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Anti-drug Antibodies: Anti-insulin Degludec Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 52', 'description': 'Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound \\& precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.', 'unitOfMeasure': 'Percentage B/T', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated". Missing data were imputed using LOCF method. This endpoint is only applicable for subjects in IDegLira and IDeg arm.'}, {'type': 'SECONDARY', 'title': 'Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at week 52', 'description': 'Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated". Missing data were imputed using LOCF method.This endpoint is only applicable for subjects in IDegLira and Lira arm.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Evaluation: Fundoscopy or Fundus Photography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'Left eye - at screening visit - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}]}, {'title': 'Left eye - at screening visit - Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Left eye - at screening visit - Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Left eye - week 52 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}]}, {'title': 'Left eye - week 52 - Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Left eye - week 52 - Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - at screening visit - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - at screening visit - Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - at screening visit - Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - week 52 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - week 52 - Abn, NCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Right eye - week 52 - Abn, CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at screening (week -2 to week 0), at week 52', 'description': "The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated". Number Analyzed = subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Evaluation: Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'At screening visit - normal', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}]}, {'title': 'At screening visit - Abn, NCS', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'At screening visit - Abn, CS', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - normal', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - Abn, NCS', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - Abn, CS', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at screening (week -2 to week 0), at week 52', 'description': "The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Evaluation: Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 52', 'description': 'Change in pulse after 52 weeks of treatment.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation "as treated".'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Insulin Degludec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'At week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1468.7', 'spread': '55.9', 'groupId': 'OG000'}, {'value': '1477.1', 'spread': '61.3', 'groupId': 'OG001'}]}]}, {'title': 'At week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2246.0', 'spread': '72.2', 'groupId': 'OG000'}, {'value': '2524.6', 'spread': '71.5', 'groupId': 'OG001'}]}]}, {'title': 'At week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2511.0', 'spread': '83.6', 'groupId': 'OG000'}, {'value': '2856.4', 'spread': '84.4', 'groupId': 'OG001'}]}]}, {'title': 'At week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2597.3', 'spread': '88.3', 'groupId': 'OG000'}, {'value': '2946.9', 'spread': '91.1', 'groupId': 'OG001'}]}]}, {'title': 'At week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2766.6', 'spread': '85.8', 'groupId': 'OG000'}, {'value': '3238.8', 'spread': '91.7', 'groupId': 'OG001'}]}]}, {'title': 'At week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2393.8', 'spread': '116.7', 'groupId': 'OG000'}, {'value': '3124.4', 'spread': '101.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Weeks 2, 8, 16, 26, 44, 52', 'description': 'Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and IDeg arm.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Liraglutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'OG001', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'classes': [{'title': 'At week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5681.3', 'spread': '49.4', 'groupId': 'OG000'}, {'value': '6081.6', 'spread': '65.4', 'groupId': 'OG001'}]}]}, {'title': 'At week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9107.8', 'spread': '61.4', 'groupId': 'OG000'}, {'value': '14539.5', 'spread': '71.0', 'groupId': 'OG001'}]}]}, {'title': 'At week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10038.1', 'spread': '69.5', 'groupId': 'OG000'}, {'value': '14046.5', 'spread': '73.0', 'groupId': 'OG001'}]}]}, {'title': 'At week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9995.3', 'spread': '77.5', 'groupId': 'OG000'}, {'value': '13904.2', 'spread': '91.8', 'groupId': 'OG001'}]}]}, {'title': 'At week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8791.7', 'spread': '81.0', 'groupId': 'OG000'}, {'value': '12855.6', 'spread': '112.7', 'groupId': 'OG001'}]}]}, {'title': 'At week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7426.2', 'spread': '103.5', 'groupId': 'OG000'}, {'value': '12127.4', 'spread': '142.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Weeks 2, 8, 16, 26, 44, 52', 'description': 'Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and Lira arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'FG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'FG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '271'}, {'groupId': 'FG002', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '248'}, {'groupId': 'FG002', 'numSubjects': '263'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 71 sites in Japan. 71 sites screened and randomised subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '819', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Degludec/Liraglutide', 'description': 'Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'BG001', 'title': 'Insulin Degludec', 'description': 'Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'BG002', 'title': 'Liraglutide', 'description': 'Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '57.2', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '581', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '819', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '819', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated Haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.52', 'spread': '1.12', 'groupId': 'BG000'}, {'value': '8.53', 'spread': '1.05', 'groupId': 'BG001'}, {'value': '8.32', 'spread': '0.99', 'groupId': 'BG002'}, {'value': '8.45', 'spread': '1.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-01', 'size': 2208970, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-07T02:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 819}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2015-11-16', 'resultsFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-17', 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight (kg)', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in body weight after 52 weeks of treatment.'}, {'measure': 'Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-52', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.'}, {'measure': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in FPG after 52 weeks'}, {'measure': 'Insulin Dose', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Actual daily total insulin dose after 52 weeks of treatment.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 7.0%', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 6.5%', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline (week 0) in waist circumference after 52 weeks of treatment.'}, {'measure': 'Change in Blood Pressure (Systolic and Diastolic)', 'timeFrame': 'Week 0, Week 52', 'description': 'Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.'}, {'measure': 'Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)', 'timeFrame': 'After 52 weeks of the treatment', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.'}, {'measure': 'Change in SMBG 9-point Profile - Mean of the 9-point Profile', 'timeFrame': 'Week 0, week 52', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.'}, {'measure': 'Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)', 'timeFrame': 'Week 0, week 52', 'description': 'Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.'}, {'measure': 'Total Cholesterol as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Triglycerides as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Free Fatty Acids as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Fasting C-peptide as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Fasting Human Insulin as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Fasting Glucagon as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Proinsulin as a Ratio to Baseline at 52 Weeks', 'timeFrame': 'After 52 weeks of treatment', 'description': 'Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.'}, {'measure': 'Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.'}, {'measure': 'Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': '0-52 weeks', 'description': 'Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition', 'timeFrame': '0-52 weeks', 'description': "Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:\n\n1. Severe hypoglycaemia\n2. Documented symptomatic hypoglycaemia\n3. Asymptomatic hypoglycaemia\n4. Probable symptomatic hypoglycaemia\n5. Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product."}, {'measure': 'Anti-drug Antibodies: Anti-insulin Degludec Antibodies', 'timeFrame': 'at week 52', 'description': 'Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound \\& precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.'}, {'measure': 'Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies', 'timeFrame': 'at week 52', 'description': 'Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.'}, {'measure': 'Change in Clinical Evaluation: Fundoscopy or Fundus Photography', 'timeFrame': 'at screening (week -2 to week 0), at week 52', 'description': "The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52."}, {'measure': 'Change in Clinical Evaluation: Electrocardiogram (ECG)', 'timeFrame': 'at screening (week -2 to week 0), at week 52', 'description': "The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52."}, {'measure': 'Change in Clinical Evaluation: Pulse', 'timeFrame': 'Week 0, week 52', 'description': 'Change in pulse after 52 weeks of treatment.'}, {'measure': 'Serum Concentrations of Insulin Degludec', 'timeFrame': 'Weeks 2, 8, 16, 26, 44, 52', 'description': 'Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.'}, {'measure': 'Plasma Concentrations of Liraglutide', 'timeFrame': 'Weeks 2, 8, 16, 26, 44, 52', 'description': 'Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '31407845', 'type': 'RESULT', 'citation': 'Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N. Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naive Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial. Diabetes Obes Metab. 2019 Dec;21(12):2674-2683. doi: 10.1111/dom.13856. Epub 2019 Aug 28.'}, {'pmid': '33595901', 'type': 'RESULT', 'citation': 'Komatsu M, Watada H, Kaneko S, Ross Agner BF, Nishida T, Kaku K. Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials. J Diabetes Investig. 2021 Sep;12(9):1610-1618. doi: 10.1111/jdi.13525. Epub 2021 Mar 24.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female Japanese subjects, age at least 20 years at the time of signing informed consent\n* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening\n* HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%\n* Body-mass index (BMI) above or equal to 20 kg/m\\^2\n* Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling\n\nExclusion Criteria:\n\n* Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening\n* Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism\n* Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal\n* Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)\n* Screening calcitonin equal to or above 50 ng/L\n* History of pancreatitis (acute or chronic)\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV'}, 'identificationModule': {'nctId': 'NCT02607306', 'acronym': 'DUAL™ I Japan', 'briefTitle': 'A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NN9068-4183'}, 'secondaryIdInfos': [{'id': 'U1111-1170-1332', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-153089', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin degludec/liraglutide OD', 'interventionNames': ['Drug: insulin degludec/liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin degludec OD', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide OD', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'insulin degludec/liraglutide', 'type': 'DRUG', 'description': 'Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.', 'armGroupLabels': ['Insulin degludec/liraglutide OD']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.', 'armGroupLabels': ['Insulin degludec OD']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.', 'armGroupLabels': ['Liraglutide OD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123-0845', 'city': 'Adachi-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '010-8543', 'city': 'Akita-shi, Akita', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '379-0116', 'city': 'Annaka-shi, Gunma', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '070-0002', 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