Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-23 @ 4:19 PM
Study NCT ID:
NCT00614120
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2008-01-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
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': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication and other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected over a time span of 16 weeks.', 'description': 'The safety analysis set is all who had been exposed to at least one dose of the study products.', 'eventGroups': [{'id': 'EG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo', 'otherNumAtRisk': 231, 'otherNumAffected': 67, 'seriousNumAtRisk': 231, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo', 'otherNumAtRisk': 233, 'otherNumAffected': 98, 'seriousNumAtRisk': 233, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo', 'otherNumAtRisk': 233, 'otherNumAffected': 113, 'seriousNumAtRisk': 233, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo', 'otherNumAtRisk': 231, 'otherNumAffected': 30, 'seriousNumAtRisk': 231, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 50, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cubital tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Benign hydatidiform mole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cryptogenic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.23', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '0.98', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.11', 'pValueComment': 'Non-inferiority; \\<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.', 'estimateComment': 'The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.', 'groupDescription': 'Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.', 'nonInferiorityComment': 'Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.20', 'pValueComment': 'In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.', 'estimateComment': 'The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.', 'groupDescription': 'Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.', 'nonInferiorityComment': 'Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.'}, {'pValue': '0.0421', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.42', 'pValueComment': 'In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.', 'estimateComment': 'The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.', 'groupDescription': 'Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.\n\nAssuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.', 'nonInferiorityComment': 'Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.'}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 16', 'description': 'Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).', 'unitOfMeasure': 'percentage point of total HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 16', 'description': 'Change in body weight from baseline (week 0) to 16 weeks (end of treatment)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Self-measured Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.83', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '-2.28', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '-2.13', 'spread': '2.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 16', 'description': 'Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': '7-point Self-measured Plasma Glucose Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'title': 'Week 0 - Before breakfast', 'categories': [{'measurements': [{'value': '168.2', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '167.5', 'spread': '42.5', 'groupId': 'OG001'}, {'value': '168.8', 'spread': '40.4', 'groupId': 'OG002'}, {'value': '163.8', 'spread': '41.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - 90 minutes after breakfast', 'categories': [{'measurements': [{'value': '245.9', 'spread': '71.6', 'groupId': 'OG000'}, {'value': '248.0', 'spread': '70.0', 'groupId': 'OG001'}, {'value': '245.4', 'spread': '63.8', 'groupId': 'OG002'}, {'value': '238.5', 'spread': '62.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - Before lunch', 'categories': [{'measurements': [{'value': '178.5', 'spread': '62.7', 'groupId': 'OG000'}, {'value': '180.5', 'spread': '63.5', 'groupId': 'OG001'}, {'value': '176.9', 'spread': '56.8', 'groupId': 'OG002'}, {'value': '175.8', 'spread': '61.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - 90 minutes after lunch', 'categories': [{'measurements': [{'value': '234.2', 'spread': '68.7', 'groupId': 'OG000'}, {'value': '232.3', 'spread': '67.0', 'groupId': 'OG001'}, {'value': '234.4', 'spread': '64.2', 'groupId': 'OG002'}, {'value': '227.6', 'spread': '67.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - Before dinner', 'categories': [{'measurements': [{'value': '194.8', 'spread': '63.0', 'groupId': 'OG000'}, {'value': '184.8', 'spread': '65.0', 'groupId': 'OG001'}, {'value': '190.9', 'spread': '61.7', 'groupId': 'OG002'}, {'value': '180.2', 'spread': '59.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - 90 minutes after dinner', 'categories': [{'measurements': [{'value': '239.6', 'spread': '65.3', 'groupId': 'OG000'}, {'value': '239.6', 'spread': '71.3', 'groupId': 'OG001'}, {'value': '244.0', 'spread': '69.8', 'groupId': 'OG002'}, {'value': '231.6', 'spread': '60.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 - Bedtime', 'categories': [{'measurements': [{'value': '205.7', 'spread': '69.6', 'groupId': 'OG000'}, {'value': '208.1', 'spread': '67.5', 'groupId': 'OG001'}, {'value': '219.3', 'spread': '71.7', 'groupId': 'OG002'}, {'value': '202.7', 'spread': '66.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - Before breakfast', 'categories': [{'measurements': [{'value': '137.0', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '130.4', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '133.7', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '130.1', 'spread': '31.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - 90 minutes after breakfast', 'categories': [{'measurements': [{'value': '198.5', 'spread': '55.8', 'groupId': 'OG000'}, {'value': '190.1', 'spread': '50.8', 'groupId': 'OG001'}, {'value': '178.5', 'spread': '48.2', 'groupId': 'OG002'}, {'value': '201.2', 'spread': '54.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - Before lunch', 'categories': [{'measurements': [{'value': '144.8', 'spread': '45.2', 'groupId': 'OG000'}, {'value': '136.5', 'spread': '41.8', 'groupId': 'OG001'}, {'value': '138.0', 'spread': '37.8', 'groupId': 'OG002'}, {'value': '132.6', 'spread': '46.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - 90 minutes after lunch', 'categories': [{'measurements': [{'value': '187.2', 'spread': '48.7', 'groupId': 'OG000'}, {'value': '176.9', 'spread': '49.5', 'groupId': 'OG001'}, {'value': '177.9', 'spread': '48.4', 'groupId': 'OG002'}, {'value': '184.3', 'spread': '54.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - Before dinner', 'categories': [{'measurements': [{'value': '159.1', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '147.8', 'spread': '40.1', 'groupId': 'OG001'}, {'value': '144.2', 'spread': '40.6', 'groupId': 'OG002'}, {'value': '143.3', 'spread': '47.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - 90 minutes after dinner', 'categories': [{'measurements': [{'value': '193.7', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '187.1', 'spread': '49.3', 'groupId': 'OG001'}, {'value': '183.3', 'spread': '53.9', 'groupId': 'OG002'}, {'value': '190.2', 'spread': '51.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 - Bedtime', 'categories': [{'measurements': [{'value': '169.1', 'spread': '51.5', 'groupId': 'OG000'}, {'value': '161.6', 'spread': '47.1', 'groupId': 'OG001'}, {'value': '155.8', 'spread': '45.6', 'groupId': 'OG002'}, {'value': '163.6', 'spread': '50.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - Before breakfast', 'categories': [{'measurements': [{'value': '137.8', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '130.2', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '130.2', 'spread': '26.8', 'groupId': 'OG002'}, {'value': '128.5', 'spread': '29.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - 90 minutes after breakfast', 'categories': [{'measurements': [{'value': '197.5', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '185.7', 'spread': '49.4', 'groupId': 'OG001'}, {'value': '178.6', 'spread': '51.6', 'groupId': 'OG002'}, {'value': '200.8', 'spread': '57.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - Before lunch', 'categories': [{'measurements': [{'value': '141.8', 'spread': '48.3', 'groupId': 'OG000'}, {'value': '135.6', 'spread': '40.3', 'groupId': 'OG001'}, {'value': '134.1', 'spread': '40.3', 'groupId': 'OG002'}, {'value': '129.3', 'spread': '47.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - 90 minutes after lunch', 'categories': [{'measurements': [{'value': '183.7', 'spread': '50.0', 'groupId': 'OG000'}, {'value': '174.7', 'spread': '46.2', 'groupId': 'OG001'}, {'value': '173.7', 'spread': '53.1', 'groupId': 'OG002'}, {'value': '185.3', 'spread': '52.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - Before dinner', 'categories': [{'measurements': [{'value': '156.4', 'spread': '44.8', 'groupId': 'OG000'}, {'value': '143.4', 'spread': '36.1', 'groupId': 'OG001'}, {'value': '144.5', 'spread': '43.0', 'groupId': 'OG002'}, {'value': '144.2', 'spread': '49.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - 90 minutes after dinner', 'categories': [{'measurements': [{'value': '197.2', 'spread': '51.8', 'groupId': 'OG000'}, {'value': '185.7', 'spread': '47.1', 'groupId': 'OG001'}, {'value': '183.5', 'spread': '51.7', 'groupId': 'OG002'}, {'value': '188.5', 'spread': '50.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 - Bedtime', 'categories': [{'measurements': [{'value': '168.2', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '158.9', 'spread': '45.3', 'groupId': 'OG001'}, {'value': '158.9', 'spread': '47.0', 'groupId': 'OG002'}, {'value': '159.9', 'spread': '47.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - Before breakfast', 'categories': [{'measurements': [{'value': '137.3', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '132.9', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '128.6', 'spread': '26.1', 'groupId': 'OG002'}, {'value': '131.0', 'spread': '35.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - 90 minutes after breakfast', 'categories': [{'measurements': [{'value': '195.6', 'spread': '57.1', 'groupId': 'OG000'}, {'value': '188.7', 'spread': '51.6', 'groupId': 'OG001'}, {'value': '177.6', 'spread': '51.6', 'groupId': 'OG002'}, {'value': '195.1', 'spread': '57.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - Before lunch', 'categories': [{'measurements': [{'value': '140.5', 'spread': '41.3', 'groupId': 'OG000'}, {'value': '137.0', 'spread': '40.3', 'groupId': 'OG001'}, {'value': '137.8', 'spread': '40.8', 'groupId': 'OG002'}, {'value': '128.8', 'spread': '45.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - 90 minutes after lunch', 'categories': [{'measurements': [{'value': '185.8', 'spread': '44.4', 'groupId': 'OG000'}, {'value': '181.4', 'spread': '46.7', 'groupId': 'OG001'}, {'value': '173.2', 'spread': '50.7', 'groupId': 'OG002'}, {'value': '182.2', 'spread': '51.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - Before dinner', 'categories': [{'measurements': [{'value': '151.5', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '148.4', 'spread': '39.8', 'groupId': 'OG001'}, {'value': '140.9', 'spread': '38.8', 'groupId': 'OG002'}, {'value': '144.9', 'spread': '45.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - 90 minutes after dinner', 'categories': [{'measurements': [{'value': '195.0', 'spread': '52.2', 'groupId': 'OG000'}, {'value': '183.3', 'spread': '46.2', 'groupId': 'OG001'}, {'value': '173.2', 'spread': '48.3', 'groupId': 'OG002'}, {'value': '192.6', 'spread': '53.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 - Bedtime', 'categories': [{'measurements': [{'value': '166.4', 'spread': '50.6', 'groupId': 'OG000'}, {'value': '159.8', 'spread': '44.7', 'groupId': 'OG001'}, {'value': '151.6', 'spread': '40.3', 'groupId': 'OG002'}, {'value': '157.7', 'spread': '47.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, 8, 12 and 16', 'description': 'Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Beta-cell Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '94.6', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '30.4', 'groupId': 'OG001'}, {'value': '21.7', 'spread': '78.5', 'groupId': 'OG002'}, {'value': '21.8', 'spread': '43.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 16', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).', 'unitOfMeasure': 'percentage point (%point)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Lipid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'title': 'Change in TC (Absolute), N=221, 216, 216, 228', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': 'Change in LDL-C (Absolute), N=221, 216, 216, 228', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.55', 'groupId': 'OG003'}]}]}, {'title': 'Change in VLDL-C (Absolute), N=213, 210, 207, 220', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Change in HDL-C (Absolute), N=217, 212, 212, 220', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-0.01', 'spread': '0.34', 'groupId': 'OG003'}]}]}, {'title': 'Change in TG (Absolute), N=220, 212, 213, 226', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '1.26', 'groupId': 'OG003'}]}]}, {'title': 'Change in FFA (Absolute), N=218, 214, 216, 227', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 16', 'description': 'Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:\n\n* Total Cholesterol (TC)\n* Low-density Lipoprotein-cholesterol (LDL-C)\n* Very Low-density Lipoprotein-cholesterol (VLDL-C)\n* High-density Lipoprotein-cholesterol (HDL-C)\n* Triglyceride (TG)\n* Free Fatty Acid (FFA)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Lipid Profile, APO-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}, {'value': '228', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'week 0, week 16', 'description': 'Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'OG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}, {'title': 'Symptoms only', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 0-16', 'description': 'Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'FG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'FG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'FG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '231'}, {'comment': 'Randomised', 'groupId': 'FG001', 'numSubjects': '233'}, {'comment': 'Randomised', 'groupId': 'FG002', 'numSubjects': '234'}, {'comment': 'Randomised', 'groupId': 'FG003', 'numSubjects': '231'}]}, {'type': 'Exposed to Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'comment': 'Subject withdrew before exposure to study products, and thus not included in full analysis set.', 'groupId': 'FG002', 'numSubjects': '233'}, {'groupId': 'FG003', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '187'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Did not meet trial criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'hCG positive (not pregnant)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Hypoglycaemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of trial product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Late syphilis, latent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Taken inhibition medication eg Prandin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 51 centres in three countries: China (17), India (24) and South Korea (10)', 'preAssignmentDetails': 'A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '929', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'BG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'BG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo'}, {'id': 'BG003', 'title': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '53.6', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '53.3', 'spread': '9.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '415', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '514', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous OAD treatment', 'classes': [{'title': 'Mono-therapy', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '289', 'groupId': 'BG004'}]}]}, {'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}, {'value': '640', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'OAD = Oral Anti-Diabetic Drug', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '3.8', 'groupId': 'BG002'}, {'value': '25.3', 'spread': '3.7', 'groupId': 'BG003'}, {'value': '25.6', 'spread': '3.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '7.5', 'spread': '5.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '1.63', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '1.62', 'spread': '0.08', 'groupId': 'BG002'}, {'value': '1.64', 'spread': '0.09', 'groupId': 'BG003'}, {'value': '1.63', 'spread': '0.09', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '68.2', 'spread': '11.9', 'groupId': 'BG003'}, {'value': '68.1', 'spread': '11.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 929}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2009-11-09', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2008-01-15', 'dispFirstSubmitQcDate': '2009-11-09', 'resultsFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2008-02-12', 'dispFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-23', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'week 0, week 16', 'description': 'Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'week 0, week 16', 'description': 'Change in body weight from baseline (week 0) to 16 weeks (end of treatment)'}, {'measure': 'Change in Self-measured Fasting Plasma Glucose', 'timeFrame': 'week 0, week 16', 'description': 'Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.'}, {'measure': '7-point Self-measured Plasma Glucose Profiles', 'timeFrame': 'week 0, 8, 12 and 16', 'description': 'Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).'}, {'measure': 'Change in Beta-cell Function', 'timeFrame': 'week 0, week 16', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).'}, {'measure': 'Change in Fasting Lipid Profile', 'timeFrame': 'week 0, week 16', 'description': 'Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:\n\n* Total Cholesterol (TC)\n* Low-density Lipoprotein-cholesterol (LDL-C)\n* Very Low-density Lipoprotein-cholesterol (VLDL-C)\n* High-density Lipoprotein-cholesterol (HDL-C)\n* Triglyceride (TG)\n* Free Fatty Acid (FFA)'}, {'measure': 'Change in Fasting Lipid Profile, APO-B', 'timeFrame': 'week 0, week 16', 'description': 'Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).'}, {'measure': 'Hypoglycaemic Episodes', 'timeFrame': 'weeks 0-16', 'description': 'Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '21114607', 'type': 'RESULT', 'citation': 'Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x.'}, {'pmid': '23010561', 'type': 'RESULT', 'citation': 'Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.'}, {'pmid': '25504028', 'type': 'RESULT', 'citation': 'Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.'}, {'pmid': '25684604', 'type': 'RESULT', 'citation': 'Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19.'}, {'pmid': '21450987', 'type': 'DERIVED', 'citation': 'Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months\n* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone\n* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy\n* BMI less than 45.0 kg/m\\^2\n\nExclusion Criteria:\n\n* Treatment with insulin within the last 3 months prior to the trial\n* Impaired liver or/and renal function\n* Significant cardiovascular disease over the last 6 months\n* Known retinopathy or maculopathy\n* Recurrent major hypoglycaemia or hypoglycaemic unawareness'}, 'identificationModule': {'nctId': 'NCT00614120', 'briefTitle': 'Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN2211-1796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg + metformin + glimepiride placebo', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg + metformin + glimepiride placebo', 'interventionNames': ['Drug: placebo', 'Drug: liraglutide', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.8 + Met', 'description': 'Liraglutide + metformin + glimepiride placebo', 'interventionNames': ['Drug: placebo', 'Drug: liraglutide', 'Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Glim + Met', 'description': 'Glimepiride 4.0 mg + metformin + liraglutide placebo', 'interventionNames': ['Drug: glimepiride', 'Drug: metformin', 'Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '0.6 mg/day, s.c. (under the skin) injection', 'armGroupLabels': ['Lira 0.6 + Met']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Glimepiride placebo, capsules', 'armGroupLabels': ['Lira 0.6 + Met', 'Lira 1.2 + Met', 'Lira 1.8 + Met']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': '1.2 mg/day, s.c. (under the skin) injection', 'armGroupLabels': ['Lira 1.2 + Met']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': '1.8 mg/day, s.c. (under the skin) injection', 'armGroupLabels': ['Lira 1.8 + Met']}, {'name': 'glimepiride', 'type': 'DRUG', 'description': 'Capsules, 4.0 mg/day', 'armGroupLabels': ['Glim + Met']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Tablets, 1.5-2.0 g/day', 'armGroupLabels': ['Glim + Met', 'Lira 0.6 + Met', 'Lira 1.2 + Met', 'Lira 1.8 + Met']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Liraglutide placebo, s.c. 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