Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-10 @ 3:16 PM
Study NCT ID:
NCT02738151
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2016-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C571886', 'term': 'insulin degludec'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events were collected from signature of the informed consent form until 7 days after last treatment administration (maximum exposure: 24 Weeks).', 'description': "Reported adverse events and death were treatment-emergent adverse events that is adverse events that developed/worsened during the 'on treatment period' (On-treatment period was defined as the time from the first injection of open-label Investigational Medicinal Product (IMP) up to 7 days after the last injection of open-label IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.', 'otherNumAtRisk': 462, 'deathsNumAtRisk': 462, 'otherNumAffected': 56, 'seriousNumAtRisk': 462, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.', 'otherNumAtRisk': 462, 'deathsNumAtRisk': 462, 'otherNumAffected': 58, 'seriousNumAtRisk': 462, 'deathsNumAffected': 0, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 49, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 45, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary Artery Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bacterial Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meniscus Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acoustic Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adenocarcinoma Of Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carcinoid Tumour Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatic Carcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Trigeminal Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcohol Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug Use Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Varicose Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.64', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.152', 'ciUpperLimit': '0.051', 'pValueComment': 'Threshold for significance at 0.025 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.052', 'estimateComment': 'Toujeo vs. Tresiba', 'groupDescription': 'A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \\<0.3%.'}, {'pValue': '0.3302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.152', 'ciUpperLimit': '0.051', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.052', 'groupDescription': 'Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \\<0 (zero).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat(ITT) population: all randomized participants who received at least 1 dose of IMP, regardless of whether treatment was actually being received \\& analyzed as per allocated treatment group. Overall number of participants analyzed=participants with at least 1 baseline \\& 1 post-baseline HbA1c assessment during 24week on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.036', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, overall number of participants analyzed = participants with at least one baseline and one post-baseline HbA1c assessment during the 12 week on-treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.64', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '0.100', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.52', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-3.95', 'spread': '0.110', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, number analyzed = participants with at least one baseline and one post baseline FPG values at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.26', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-3.25', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.23', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '0.068', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, overall number analyzed =participants with at least one baseline and one post baseline fasting SMPG values at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12: 03:00 at night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.77', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.42', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-3.00', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 hours after breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.20', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.64', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 hours after lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.51', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '3.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.04', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '3.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 hours after dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.32', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '3.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 03:00 at night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.37', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 hours after breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.30', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-3.50', 'spread': '4.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.81', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '-2.29', 'spread': '3.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 hours after lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.74', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.87', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 hours after dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.28', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '4.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.52', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '-2.09', 'spread': '3.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number Analyzed = participants with at least one baseline and one post baseline 8 Point SMPG values at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12: Pre-breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.41', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.03', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '3.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.41', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-breakfast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.38', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-2.99', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-lunch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.81', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-dinner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.88', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '4.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.51', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '-2.10', 'spread': '4.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number analyzed = Participants with at least one baseline and one post-baseline 4-point SMPG values at specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.57', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.62', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '0.096', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '0.416', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.391', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.390', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit.', 'unitOfMeasure': 'percentage of mean variability', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number Analyzed = participants with at least one baseline and one post baseline Fasting SMPG values at specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '0.562', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '0.561', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.70', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '0.599', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Adjusted LS means were obtained from MMRM.', 'unitOfMeasure': 'percentage of mean variability', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Participants who reached the target <7% at Week 12', 'categories': [{'measurements': [{'value': '34.63', 'groupId': 'OG000'}, {'value': '36.15', 'groupId': 'OG001'}]}]}, {'title': 'Participants who reached target <=6.5% at Week 12', 'categories': [{'measurements': [{'value': '11.47', 'groupId': 'OG000'}, {'value': '14.29', 'groupId': 'OG001'}]}]}, {'title': 'Participants who reached the target <7% at Week 24', 'categories': [{'measurements': [{'value': '48.70', 'groupId': 'OG000'}, {'value': '44.59', 'groupId': 'OG001'}]}]}, {'title': 'Participants who reached target <=6.5% at Week 24', 'categories': [{'measurements': [{'value': '21.21', 'groupId': 'OG000'}, {'value': '19.70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, and Week 24', 'description': 'Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week12: Participants who reached the target <7%', 'categories': [{'measurements': [{'value': '16.45', 'groupId': 'OG000'}, {'value': '13.64', 'groupId': 'OG001'}]}]}, {'title': 'Week12: Participants who reached target <=6.5%', 'categories': [{'measurements': [{'value': '4.11', 'groupId': 'OG000'}, {'value': '4.55', 'groupId': 'OG001'}]}]}, {'title': 'Week24: Participants who reached the target <7%', 'categories': [{'measurements': [{'value': '13.42', 'groupId': 'OG000'}, {'value': '12.99', 'groupId': 'OG001'}]}]}, {'title': 'Week24: Participants who reached target <=6.5%', 'categories': [{'measurements': [{'value': '5.84', 'groupId': 'OG000'}, {'value': '5.19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, and Week 24', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =\\<3.9 mmol/L (=\\<70 mg/dL).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.98', 'groupId': 'OG000'}, {'value': '4.76', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000'}, {'value': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG \\>200 mg/dL (11 mmol/L), or HbA1c \\>8.5%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.289', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.255', 'spread': '0.195', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.357', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.309', 'spread': '0.241', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.', 'unitOfMeasure': 'Units per kilogram (U/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Any hypo Day1-Week 12', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}, {'value': '58.4', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo Week13-14', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo 24 week period', 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}, {'value': '71.2', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL) D1-W12', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL) W13-14', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '55.8', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(=<70mg/dL) 24W period', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (< 54mg/dL) D1-W12', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo( <54 mg/dL) W13-14', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (<54mg/dL) 24W period', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Assessment was done by treatment period (for =\\<12 weeks, for \\>12 weeks to =\\<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Any hypo D1-W12', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo W13-14', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo 24Week period', 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL)D1-W12', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL)W13-14', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(=<70mg/dL)24W Period', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)D1-W12', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)W13-14', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)24W Period', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =\\<12 weeks, for \\>12 weeks to =\\<24 weeks).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Any hypo Day1-Week12', 'categories': [{'measurements': [{'value': '8.93', 'groupId': 'OG000'}, {'value': '11.31', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo Week13-14', 'categories': [{'measurements': [{'value': '11.28', 'groupId': 'OG000'}, {'value': '11.60', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo 24 Week period', 'categories': [{'measurements': [{'value': '10.09', 'groupId': 'OG000'}, {'value': '11.45', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL) D1-W12', 'categories': [{'measurements': [{'value': '8.08', 'groupId': 'OG000'}, {'value': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (=<70mg/dL) W13-14', 'categories': [{'measurements': [{'value': '10.64', 'groupId': 'OG000'}, {'value': '11.21', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (≤70mg/dL) 24W period', 'categories': [{'measurements': [{'value': '9.34', 'groupId': 'OG000'}, {'value': '10.83', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (< 54mg/dL) D1-W12', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000'}, {'value': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo( <54 mg/dL) W13-14', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000'}, {'value': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo (<54mg/dL) 24W period', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}, {'value': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L).', 'unitOfMeasure': 'Events per participant year', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.08', 'spread': '0.246', 'groupId': 'OG000'}, {'value': '5.32', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.77', 'spread': '0.257', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '0.256', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': "The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number Analyzed = participants with at least one baseline and one post-baseline DTSQ status (DTSQs) total score.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'OG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'classes': [{'title': 'Any hypo D1-W12', 'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000'}, {'value': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo W13-14', 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000'}, {'value': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Any hypo 24Week period', 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000'}, {'value': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(=<70mg/dL)D1-W12', 'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000'}, {'value': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(=<70mg/dL)W13-14', 'categories': [{'measurements': [{'value': '2.24', 'groupId': 'OG000'}, {'value': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(=<70mg/dL)24W Period', 'categories': [{'measurements': [{'value': '1.83', 'groupId': 'OG000'}, {'value': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)D1-W12', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}, {'value': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)W13-14', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Severe and/or confirmed hypo(< 54mg/dL)24W Period', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000'}, {'value': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time).', 'unitOfMeasure': 'Events per participant year', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'FG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}, {'groupId': 'FG001', 'numSubjects': '463'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '462'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}, {'groupId': 'FG001', 'numSubjects': '432'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor Compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'The study was conducted at 158 study centers across 16 countries. A total of 1376 participants were screened between 19 May 2016 and 19 February 2017, of whom 447 were screen failures.', 'preAssignmentDetails': "A total of 929 participants were randomized in 1:1 ratio to either Toujeo or Tresiba, stratified by screening glycated hemoglobin (HbA1c) values (\\<8% or \\>=8%); and use of sulfonylurea (SU) or meglitinides before the day of screening ('yes' versus 'no')."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'BG001', 'title': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '430', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Type 2 Diabetes Mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '10.6', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HbA1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '929', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.71', 'spread': '0.83', 'groupId': 'BG000'}, {'value': '8.57', 'spread': '0.80', 'groupId': 'BG001'}, {'value': '8.64', 'spread': '0.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Basal Insulin Daily Dose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '461', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '922', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.04', 'groupId': 'BG000'}, {'value': '0.12', 'spread': '0.03', 'groupId': 'BG001'}, {'value': '0.15', 'spread': '0.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Units per kilogram (U/kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed = participants with available data for specified measure.'}], 'populationDescription': 'Baseline population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-18', 'size': 585961, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-18T10:25', 'hasProtocol': True}, {'date': '2017-07-03', 'size': 918983, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-18T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 929}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-19'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2016-03-31', 'resultsFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2016-04-08', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-14', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': "The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM."}], 'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c to Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period.'}, {'measure': 'Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period.'}, {'measure': 'Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.'}, {'measure': 'Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.'}, {'measure': 'Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM.'}, {'measure': 'Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit.'}, {'measure': 'Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Adjusted LS means were obtained from MMRM.'}, {'measure': 'Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24', 'timeFrame': 'Week 12, and Week 24', 'description': 'Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.'}, {'measure': 'Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event', 'timeFrame': 'Week 12, and Week 24', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =\\<3.9 mmol/L (=\\<70 mg/dL).'}, {'measure': 'Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period', 'timeFrame': 'Baseline to Week 24', 'description': 'Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis.'}, {'measure': 'Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period', 'timeFrame': 'Baseline to Week 24', 'description': 'Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG \\>200 mg/dL (11 mmol/L), or HbA1c \\>8.5%.'}, {'measure': 'Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.'}, {'measure': 'Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Assessment was done by treatment period (for =\\<12 weeks, for \\>12 weeks to =\\<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported.'}, {'measure': 'Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =\\<12 weeks, for \\>12 weeks to =\\<24 weeks).'}, {'measure': 'Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L).'}, {'measure': 'Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period', 'timeFrame': 'Day 1-Week 12, Week 13-Week 24, and 24 Week Period', 'description': 'Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\\<70 mg/dL (=\\<3.9 mmol/L), or \\< 54 mg/dL (\\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '30104294', 'type': 'DERIVED', 'citation': 'Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frias JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.\n\nSecondary Objectives:\n\nChange From Baseline in HbA1c to Week 12\n\nTo assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:\n\n* Change in Fasting plasma glucose (FPG);\n* Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;\n* Percentage of participants reaching HbA1c targets \\<7% or ≤6.5%;\n* Percentage of participants reaching HbA1c targets \\<7% or ≤6.5% without severe and/or confirmed hypoglycemia\n* Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.\n\nTo assess the safety in each treatment group.\n\nTo assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).\n\nPercentage of participants requiring rescue therapy.', 'detailedDescription': 'The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Age \\<18 years.\n* HbA1c \\<7.5% or \\>10.5% (at screening visit). Body mass index (BMI) \\<25 kg/m\\^2 or \\>40 kg/m\\^2.\n* History of T2DM for less than 1 year before screening.\n* Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).\n* Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.\n* Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.\n* Participant receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.\n* History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.\n* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.\n* End stage renal disease.\n* Any acute or chronic condition that in the opinion of Investigator would affect the safety of participant, compliance, or study results.\n* Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.\n* Pregnant or breast-feeding women.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02738151', 'acronym': 'BRIGHT', 'briefTitle': 'Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist', 'orgStudyIdInfo': {'id': 'LPS14584'}, 'secondaryIdInfos': [{'id': '2015-005101-36', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1177-6327', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toujeo', 'description': 'Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.', 'interventionNames': ['Drug: Insulin glargine, 300U/mL', 'Drug: Non-insulin anti-diabetic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tresiba', 'description': 'Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .', 'interventionNames': ['Drug: Insulin degludec, 100 U/mL', 'Drug: Non-insulin anti-diabetic treatment']}], 'interventions': [{'name': 'Insulin glargine, 300U/mL', 'type': 'DRUG', 'otherNames': ['HOE901-U300', 'Toujeo'], 'description': 'Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).', 'armGroupLabels': ['Toujeo']}, {'name': 'Insulin degludec, 100 U/mL', 'type': 'DRUG', 'otherNames': ['Tresiba'], 'description': 'Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Tresiba']}, {'name': 'Non-insulin anti-diabetic treatment', 'type': 'DRUG', 'description': 'Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.', 'armGroupLabels': ['Toujeo', 'Tresiba']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840038', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840066', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840051', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840081', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840016', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840002', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840091', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840058', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840021', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840087', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840030', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840065', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840075', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840076', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840026', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840052', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840080', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840018', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840071', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840085', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '30461', 'city': 'Statesboro', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840072', 'geoPoint': {'lat': 32.44879, 'lon': -81.78317}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840039', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840036', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840010', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 840005', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '51501', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840063', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '50134', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840098', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840101', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840096', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '40361', 'city': 'Paris', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840061', 'geoPoint': {'lat': 38.2098, 'lon': -84.25299}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840011', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840001', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48504', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840041', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840057', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840033', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '38654', 'city': 'Olive Branch', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Investigational Site Number 840084', 'geoPoint': {'lat': 34.96176, 'lon': -89.82953}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840048', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89117', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840023', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number 840045', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07036', 'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 840031', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840060', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28655', 'city': 'Morganton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840064', 'geoPoint': {'lat': 35.74541, 'lon': -81.68482}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840043', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840082', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 840025', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 840022', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840029', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '19335', 'city': 'Downingtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 840056', 'geoPoint': {'lat': 40.0065, 'lon': -75.70327}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840093', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840097', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840070', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29582', 'city': 'North Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840044', 'geoPoint': {'lat': 33.81601, 'lon': -78.68002}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 840069', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840079', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840006', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37912', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840088', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37825', 'city': 'New Tazewell', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 840077', 'geoPoint': {'lat': 36.44258, 'lon': -83.59963}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840007', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840086', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77061', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840027', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77083-4436', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840004', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840040', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77095', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840046', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840054', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840017', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '77459', 'city': 'Missouri City', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840008', 'geoPoint': {'lat': 29.61857, 'lon': -95.53772}}, {'zip': '78229-3907', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840094', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840009', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '76710', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840053', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 840095', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 840032', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 840024', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 840020', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 840012', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 100001', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1505', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 100002', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 100003', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Investigational Site Number 191001', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Investigational Site Number 191002', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Investigational Site Number 191003', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Hlučín', 'country': 'Czechia', 'facility': 'Investigational Site Number 203009', 'geoPoint': {'lat': 49.89795, 'lon': 18.19196}}, {'zip': '25401', 'city': 'Jílové u Prahy', 'country': 'Czechia', 'facility': 'Investigational Site Number 203006', 'geoPoint': {'lat': 49.89545, 'lon': 14.49333}}, {'zip': '46001', 'city': 'Liberec', 'country': 'Czechia', 'facility': 'Investigational Site Number 203005', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'zip': '53002', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Investigational Site Number 203001', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '11000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203007', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203008', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '18100', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203002', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '75501', 'city': 'Vsetín', 'country': 'Czechia', 'facility': 'Investigational Site Number 203004', 'geoPoint': {'lat': 49.33871, 'lon': 17.99619}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Investigational Site Number 208003', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Investigational Site Number 208002', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '2400', 'city': 'København NV', 'country': 'Denmark', 'facility': 'Investigational Site Number 208001', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Investigational Site Number 208004', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '85025', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Investigational Site Number 250002', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Investigational Site Number 250003', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Investigational Site Number 250001', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Investigational Site Number 250006', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Investigational Site Number 250005', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '69200', 'city': 'Vénissieux', 'country': 'France', 'facility': 'Investigational Site Number 250007', 'geoPoint': {'lat': 45.69706, 'lon': 4.88593}}, {'zip': '68100', 'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'Investigational Site Number 300005', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'zip': '17562', 'city': 'Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300001', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300002', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Investigational Site Number 300003', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '1042', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 348004', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 348002', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1106', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigational Site Number 348001', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3200', 'city': 'Gyöngyös', 'country': 'Hungary', 'facility': 'Investigational Site Number 348003', 'geoPoint': {'lat': 47.78257, 'lon': 19.928}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigational Site Number 376001', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigational Site Number 376004', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigational Site Number 376008', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Investigational Site Number 376009', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Investigational Site Number 376002', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 376006', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 376007', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Investigational Site Number 376003', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Investigational Site Number 380007', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Investigational Site Number 380009', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '66013', 'city': 'Chieti', 'country': 'Italy', 'facility': 'Investigational Site Number 380010', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Investigational Site Number 380014', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '10024', 'city': 'Moncalieri', 'country': 'Italy', 'facility': 'Investigational Site Number 380002', 'geoPoint': {'lat': 44.9994, 'lon': 7.68236}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Investigational Site Number 380011', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number 380008', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number 380015', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number 380016', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20099', 'city': 'Sesto San Giovanni', 'country': 'Italy', 'facility': 'Investigational Site Number 380013', 'geoPoint': {'lat': 45.53329, 'lon': 9.22585}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Investigational Site Number 380005', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Investigational Site Number 380012', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '500097', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Investigational Site Number 642007', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '500326', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Investigational Site Number 642008', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '022441', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Investigational Site Number 642001', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '040172', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Investigational Site Number 642013', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Investigational Site Number 642015', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Investigational Site Number 642003', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '900675', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Investigational Site Number 642009', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '700547', 'city': 'Iași', 'country': 'Romania', 'facility': 'Investigational Site Number 642014', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Oradea', 'country': 'Romania', 'facility': 'Investigational Site Number 642005', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'city': 'Oradea', 'country': 'Romania', 'facility': 'Investigational Site Number 642012', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '540015', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Investigational Site Number 642010', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '540142', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Investigational Site Number 642004', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Investigational Site Number 642006', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Investigational Site Number 688001', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'Investigational Site Number 688002', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'Investigational Site Number 688003', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'zip': '04013', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Investigational Site Number 703006', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '03491', 'city': 'Ľubochňa', 'country': 'Slovakia', 'facility': 'Investigational Site Number 703002', 'geoPoint': {'lat': 49.12011, 'lon': 19.16891}}, {'zip': '04525', 'city': 'Moldava nad Bodvou', 'country': 'Slovakia', 'facility': 'Investigational Site Number 703001', 'geoPoint': {'lat': 48.61428, 'lon': 20.99957}}, {'zip': '08301', 'city': 'Sabinov', 'country': 'Slovakia', 'facility': 'Investigational Site Number 703003', 'geoPoint': {'lat': 49.10309, 'lon': 21.0988}}, {'zip': '07501', 'city': 'Trebišov', 'country': 'Slovakia', 'facility': 'Investigational Site Number 703005', 'geoPoint': {'lat': 48.62858, 'lon': 21.71954}}, {'zip': '22241', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Investigational Site Number 752102', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '54150', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'Investigational Site Number 752101', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '4600', 'city': 'Olten', 'country': 'Switzerland', 'facility': 'Investigational Site Number 756003', 'geoPoint': {'lat': 47.34999, 'lon': 7.90329}}, {'zip': '9016', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Investigational Site Number 756001', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'KT160PZ', 'city': 'Chertsey', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826001', 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'zip': 'ME75NY', 'city': 'Gillingham', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826005', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'LN25QY', 'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826008', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'SW109NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826002', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M415SL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826009', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CT94ANA', 'city': 'Margate', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826006', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'zip': 'SA66NL', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826004', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}