Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT02787551
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period
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': 'C479460', 'term': 'lixisenatide'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'C534611', 'term': 'rGLP-1 protein'}, {'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], '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'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of informed consent until the end of the study (up to 52 weeks).', 'description': 'Reported AEs are treatment-emergent that is AEs that developed/worsened during during the period from the administration of first dose of the study treatments up to 3 days (9 days for the weekly GLP1) after the last administration. Analysis was performed on safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Fixed Ratio Combination', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted (median exposure: 183 days).', 'otherNumAtRisk': 255, 'deathsNumAtRisk': 255, 'otherNumAffected': 69, 'seriousNumAtRisk': 255, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization (median exposure: 183 days).', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 48, 'seriousNumAtRisk': 256, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Fixed Ratio Combination Whole Study Period', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted (median exposure: 365 days).', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 75, 'seriousNumAtRisk': 206, 'deathsNumAffected': 1, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 30, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 37, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}], 'seriousEvents': [{'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Ischaemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Infected Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Postoperative Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Subcutaneous Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Electrolyte Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Spinal Column Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Adenosquamous Cell Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Bladder Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Endometrial Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Hepatic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Papillary Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Diabetic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Hypoglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Intraventricular Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Dermal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}, {'term': 'Vasculitis Necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.048', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-0.770', 'ciUpperLimit': '-0.508', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.067', 'groupDescription': 'Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (mITT) population:all randomized participants who had a baseline and at least 1 post-baseline assessment of any primary/secondary outcome measures, irrespective of compliance with study protocol and procedures."Overall number of participants analyzed"=participants with baseline and at least 1 post-baseline HbA1c assessment.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.063', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 52 value.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period. Here, "Overall number of participants analyzed" = participants with baseline and at least 1 post-baseline HbA1c assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'title': 'HbA1c <7%', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <=6.5%', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.05', 'ciLowerLimit': '28.11', 'ciUpperLimit': '43.99', 'pValueComment': 'Threshold for significance \\<=0.05', 'groupDescription': 'HbA1c \\<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \\< 7% was part of testing).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Participants without any available HbA1c assessment at Week 26 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'title': 'HbA1c <7%', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}]}]}, {'title': 'HbA1c <=6.5%', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Participants without any available HbA1c assessment at Week 52 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.28', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.67', 'ciLowerLimit': '-2.001', 'ciUpperLimit': '-1.341', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.168', 'groupDescription': 'Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.', 'unitOfMeasure': 'millimoles per litre (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline FPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.27', 'spread': '0.173', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 52 value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline FPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.69', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-1.325', 'ciUpperLimit': '-0.708', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline 7-point SMPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.176', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline 7-point SMPG assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.96', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.205', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.85', 'ciLowerLimit': '-3.420', 'ciUpperLimit': '-2.279', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.290', 'groupDescription': 'Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline plasma glucose assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.30', 'spread': '0.284', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline plasma glucose assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.51', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.173', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.468', 'ciUpperLimit': '-0.508', 'pValueComment': 'Threshold for significance at 0.05 level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\\<8.0%, \\>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': '2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and Week 26 assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.85', 'spread': '0.209', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and Week 52 assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 26', 'description': 'Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \\>8%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 26 to Week 52', 'description': 'Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \\>8%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population who entered the extension period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 26: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.89', 'spread': '0.222', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.220', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 26 value.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline body weight assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight to Week 52: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.78', 'spread': '0.294', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 52 value.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline body weight assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'OG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'classes': [{'title': 'Documented symptomatic hypoglycemia(<=3.9 mmol/L)', 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000'}, {'value': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Documented symptomatic hypoglycemia (<3.0 mmol/L)', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 26', 'description': 'Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \\<3.0 mmol/L (54 mg/dL) were also analyzed.', 'unitOfMeasure': 'events per participant-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population which included all randomized participants who received at least one dose of open-label IMP, regardless of the amount of treatment administered. Participants were analyzed according to the treatment actually received (as treated).'}, {'type': 'SECONDARY', 'title': 'Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}], 'classes': [{'title': 'Documented symptomatic hypoglycemia(<=3.9 mmol/L)', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Documented symptomatic hypoglycemia (<3.0 mmol/L)', 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 52', 'description': 'Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \\<3.0 mmol/L (54 mg/dL) were also analyzed.', 'unitOfMeasure': 'events per participant-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population who entered the extension period and their data for whole study duration was analyzed and reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Core period: FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.\n\nSingle arm extension period: participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.'}, {'id': 'FG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'Core Period: GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}], 'periods': [{'title': 'Core Period: 26 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Out of 230 participants, 206 participants entered in single arm extension period.', 'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Period:26 Weeks(Upto 52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed core period and met eligibility criteria for extension period.', 'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 112 sites in 9 countries. A total of 840 participants were screened between 06 July 2016 and 01 November 2017, of which 326 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level lesser than (\\<)7% or more than (\\>)9% at screening visit.', 'preAssignmentDetails': 'A total of 514 participants were randomized in 1:1 (Insulin Glargine/Lixisenatide fixed ratio combination \\[FRC\\] or glucagon-like peptide-1 receptor agonist \\[GLP-1 RA\\]) ratio. Randomization was stratified by values of HbA1c at screening (\\<8%, \\>=8%) \\& GLP-1 RA subtype at screening (once/twice daily \\[QD/BID\\], once weekly \\[QW\\] formulations).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted.'}, {'id': 'BG001', 'title': 'GLP-1 Receptor Agonist', 'description': 'GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.2', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Oriental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}]}, {'title': "Unknown or Not Reported'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': '<30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': '>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.23', 'spread': '7.42', 'groupId': 'BG000'}, {'value': '10.95', 'spread': '6.08', 'groupId': 'BG001'}, {'value': '11.09', 'spread': '6.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1C (HbA1C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.78', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '7.80', 'spread': '0.56', 'groupId': 'BG001'}, {'value': '7.79', 'spread': '0.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daily dose of metformin at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1966.93', 'spread': '434.56', 'groupId': 'BG000'}, {'value': '2030.74', 'spread': '497.15', 'groupId': 'BG001'}, {'value': '1998.83', 'spread': '467.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daily dose of pioglitazone at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.25', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '32.73', 'spread': '8.83', 'groupId': 'BG001'}, {'value': '32.21', 'spread': '9.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed=number of participants with available data for specified measure.'}, {'title': 'Daily dose of SGLT2 inhibitor at baseline', 'classes': [{'title': 'Canagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '214.29', 'spread': '106.90', 'groupId': 'BG000'}, {'value': '283.33', 'spread': '57.74', 'groupId': 'BG001'}, {'value': '257.89', 'spread': '83.77', 'groupId': 'BG002'}]}]}, {'title': 'Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.42', 'spread': '7.49', 'groupId': 'BG000'}, {'value': '16.67', 'spread': '8.20', 'groupId': 'BG001'}, {'value': '16.17', 'spread': '7.67', 'groupId': 'BG002'}]}]}, {'title': 'Dapagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.62', 'spread': '3.80', 'groupId': 'BG000'}, {'value': '9.00', 'spread': '2.24', 'groupId': 'BG001'}, {'value': '9.44', 'spread': '3.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number analyzed=number of participants with available data for specified categories.'}, {'title': 'Duration of GLP-1 receptor agonist treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '1.76', 'groupId': 'BG000'}, {'value': '1.92', 'spread': '1.85', 'groupId': 'BG001'}, {'value': '1.90', 'spread': '1.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'GLP-1 receptor agonist use by type at screening', 'classes': [{'title': 'Once/twice daily formulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': 'Once weekly formulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on randomized population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-12', 'size': 2155100, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-23T12:12', 'hasProtocol': True}, {'date': '2017-09-07', 'size': 1279256, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-23T12:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2016-05-26', 'resultsFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-23', 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.'}, {'measure': 'Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in HbA1c was calculated by subtracting baseline value from Week 52 value.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period', 'timeFrame': 'Week 26', 'description': 'Participants without any available HbA1c assessment at Week 26 were considered as non-responders.'}, {'measure': 'Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period', 'timeFrame': 'Week 52', 'description': 'Participants without any available HbA1c assessment at Week 52 were considered as non-responders.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in FPG was calculated by subtracting baseline value from Week 52 value.'}, {'measure': 'Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': 'The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.'}, {'measure': 'Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': 'The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.'}, {'measure': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).'}, {'measure': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': 'The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.'}, {'measure': 'Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': '2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.'}, {'measure': 'Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': '2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.'}, {'measure': 'Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period', 'timeFrame': 'From Baseline to Week 26', 'description': 'Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \\>8%.'}, {'measure': 'Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period', 'timeFrame': 'From Week 26 to Week 52', 'description': 'Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \\>8%.'}, {'measure': 'Change From Baseline in Body Weight at Week 26: Core Period', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 26 value.'}, {'measure': 'Change From Baseline in Body Weight to Week 52: Single Arm Extension Period', 'timeFrame': 'Baseline, Week 52', 'description': 'Change in body weight was calculated by subtracting baseline value from Week 52 value.'}, {'measure': 'Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period', 'timeFrame': 'From Baseline to Week 26', 'description': 'Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \\<3.0 mmol/L (54 mg/dL) were also analyzed.'}, {'measure': 'Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period', 'timeFrame': 'From Baseline to Week 52', 'description': 'Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \\<3.0 mmol/L (54 mg/dL) were also analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35332216', 'type': 'DERIVED', 'citation': 'Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.'}, {'pmid': '35257461', 'type': 'DERIVED', 'citation': 'Ferrannini E, Niemoeller E, Dex T, Servera S, Mari A. Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ss-cell function in people with type 2 diabetes. Diabetes Obes Metab. 2022 Jun;24(6):1159-1165. doi: 10.1111/dom.14688. Epub 2022 Mar 28.'}, {'pmid': '34894329', 'type': 'DERIVED', 'citation': 'Guja C, Giorgino F, Blonde L, Ali A, Prazny M, Meier JJ, Souhami E, Lubwama R, Ji C, Rosenstock J. Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results. Diabetes Ther. 2022 Jan;13(1):205-215. doi: 10.1007/s13300-021-01180-1. Epub 2021 Dec 11.'}, {'pmid': '33468520', 'type': 'DERIVED', 'citation': 'Blonde L, Rosenstock J, Frias J, Birkenfeld AL, Niemoeller E, Souhami E, Ji C, Del Prato S, Aroda VR. Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. Diabetes Care. 2021 Mar;44(3):774-780. doi: 10.2337/dc20-2023. Epub 2021 Jan 19.'}, {'pmid': '31530665', 'type': 'DERIVED', 'citation': 'Blonde L, Rosenstock J, Del Prato S, Henry R, Shehadeh N, Frias J, Niemoeller E, Souhami E, Ji C, Aroda VR. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019 Nov;42(11):2108-2116. doi: 10.2337/dc19-1357. Epub 2019 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.\n\nSecondary Objectives:\n\nTo compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \\[SGLT2\\] inhibitor) in participants with type 2 diabetes.\n\nTo evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.', 'detailedDescription': 'The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.\n\nMaximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.\n\nAll primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participants with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.\n* Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months prior to screening visit (V1):\n* Liraglutide (Victoza®) 1.8 milligram (mg) QD or 1.2 mg QD, if the 1.8 mg QD dose was not well tolerated according to the Investigator's judgment or\n* Exenatide (Byetta®) 10 microgram (µg) BID or of 5 µg BID, if 10 µg BID dose was not well tolerated according to the Investigator's judgment\n\nin combination with metformin (daily dose greater than equal to \\[\\>=\\] 1500 mg/day or maximum tolerated dose \\[MTD\\]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.\n\nor\n\nParticipants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):\n\n* Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,\n* Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW was not well tolerated according to Investigator's judgment,\n* Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW was not well tolerated according to Investigator's judgment\n\nin combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;\n\n-Signed written informed consent.\n\nExclusion criteria:\n\n* At screening visit, age \\<18.\n* Screening HbA1c \\<7% and \\>9%.\n* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.\n* Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.\n* Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin \\[\\<=10 days\\] due to intercurrent illness including gestational diabetes was allowed at the discretion of the study physician).\n* Laboratory findings at the time of screening, including:\n* Fasting plasma glucose (FPG) \\>250 mg/dL (13.9 millimoles per litre \\[mmol/L\\]),\n* Amylase and/or lipase \\>3 times the upper limit of the normal laboratory range (ULN),\n* Alanine transaminase or aspartate transaminase \\>3 ULN,\n* Calcitonin \\>=20 pg/mL (5.9 pmol/L),\n* Positive pregnancy test.\n* Participant who had renal function impairment with estimated glomerular filtration rate \\<30mL/min/1.73m\\^2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.\n* Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.\n* Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.\n* History of hypersensitivity to insulin glargine, or to any of the excipients.\n* History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.\n* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).\n* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy.\n* Body mass index \\<=20 or \\>40 kg/m\\^2.\n\nExclusion criteria for the extension period:\n\n* Participants in the FRC arm with a rescue therapy and HbA1c \\>8% at week 22.\n* Participants in the FRC arm who discontinued prematurely from FRC treatment before week 26.\n* Participants in the GLP-1 RA treatment arm after randomization.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02787551', 'acronym': 'LixiLan-G', 'briefTitle': 'Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period', 'orgStudyIdInfo': {'id': 'EFC13794'}, 'secondaryIdInfos': [{'id': '2014-004850-32'}, {'id': 'U1111-1168-4639', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)', 'description': 'Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.\n\nSingle arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.', 'interventionNames': ['Drug: Insulin glargine/lixisenatide fixed ratio combination', 'Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1 Receptor Agonist', 'description': 'Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \\[BID\\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.', 'interventionNames': ['Drug: liraglutide', 'Drug: exenatide', 'Drug: exenatide extended-release', 'Drug: albiglutide', 'Drug: dulaglutide', 'Drug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)']}], 'interventions': [{'name': 'Insulin glargine/lixisenatide fixed ratio combination', 'type': 'DRUG', 'otherNames': ['HOE901/AVE0010', 'Soliqua'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)']}, {'name': 'liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['GLP-1 Receptor Agonist']}, {'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['GLP-1 Receptor Agonist']}, {'name': 'exenatide extended-release', 'type': 'DRUG', 'otherNames': ['Bydureon'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['GLP-1 Receptor Agonist']}, {'name': 'albiglutide', 'type': 'DRUG', 'otherNames': ['Tanzeum'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['GLP-1 Receptor Agonist']}, {'name': 'dulaglutide', 'type': 'DRUG', 'otherNames': ['Trulicity'], 'description': 'Pharmaceutical form: solution for injection\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['GLP-1 Receptor Agonist']}, {'name': 'Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.', 'armGroupLabels': ['GLP-1 Receptor Agonist', 'Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 8400064', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85268', 'city': 'Fountain Hills', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8400073', 'geoPoint': {'lat': 33.61171, 'lon': -111.71736}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8400047', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400103', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400137', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400043', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '93241', 'city': 'Lamont', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400124', 'geoPoint': {'lat': 35.25968, 'lon': -118.91427}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400027', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400098', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400013', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400042', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400006', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400021', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400126', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400094', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400009', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 8400071', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 8400036', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400114', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400133', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, 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{'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Investigational Site Number 7240008', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'country': 'Spain', 'facility': 'Investigational Site Number 7240011', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '46930', 'city': 'Quart de Poblet', 'country': 'Spain', 'facility': 'Investigational Site Number 7240003', 'geoPoint': {'lat': 39.48139, 'lon': -0.43937}}, {'zip': '08208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Investigational Site Number 7240006', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', 'facility': 'Investigational Site Number 7240007', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Investigational Site Number 7240009', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', 'facility': 'Investigational Site Number 7240004', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. 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