Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT03285594
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
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': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medical-information@lexpharma.com', 'phone': '(510) 338-6064', 'title': 'Medical Affairs', 'organization': 'Lexicon Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks', 'description': 'Safety population included all randomized participants who had received at least 1 dose of double-blind investigational medicinal product (regardless of the amount of treatment administered). Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 30, 'seriousNumAtRisk': 144, 'deathsNumAffected': 2, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 18, 'seriousNumAtRisk': 141, 'deathsNumAffected': 1, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'otherNumAtRisk': 285, 'deathsNumAtRisk': 285, 'otherNumAffected': 45, 'seriousNumAtRisk': 285, 'deathsNumAffected': 6, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Postoperative thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Reperfusion arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinopathy proliferative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Infected bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Enlarged uvula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.056', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.638', 'ciUpperLimit': '-0.271', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.706', 'ciUpperLimit': '-0.387', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.081', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 18', 'description': 'An analysis of covariance (ANCOVA) model was used for the analysis.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.882', 'spread': '3.6045', 'groupId': 'OG000'}, {'value': '-2.975', 'spread': '3.6083', 'groupId': 'OG001'}, {'value': '-8.949', 'spread': '2.7550', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.858', 'ciLowerLimit': '-24.8845', 'ciUpperLimit': '-6.8309', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.6056', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.832', 'ciLowerLimit': '-29.7725', 'ciUpperLimit': '-13.8911', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.0514', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 18', 'description': 'FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.249', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.250', 'groupId': 'OG001'}, {'value': '-1.37', 'spread': '0.190', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-1.716', 'ciUpperLimit': '-0.462', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.73', 'ciLowerLimit': '-2.274', 'ciUpperLimit': '-1.183', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.278', 'groupDescription': 'The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 18', 'description': 'An ANCOVA model was used for the analysis.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.67', 'spread': '1.470', 'groupId': 'OG000'}, {'value': '-8.58', 'spread': '1.447', 'groupId': 'OG001'}, {'value': '-8.50', 'spread': '1.103', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.91', 'ciLowerLimit': '-7.642', 'ciUpperLimit': '-0.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.904', 'groupDescription': 'The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0239', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.83', 'ciLowerLimit': '-7.161', 'ciUpperLimit': '-0.507', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.697', 'groupDescription': 'The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants with baseline SBP ≥ 130 mmHg in ITT population where, ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP at Week 12 for All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.120', 'groupId': 'OG000'}, {'value': '-5.15', 'spread': '1.117', 'groupId': 'OG001'}, {'value': '-4.10', 'spread': '0.867', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.94', 'ciLowerLimit': '-7.73', 'ciUpperLimit': '-2.142', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.425', 'groupDescription': 'The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.89', 'ciLowerLimit': '-6.333', 'ciUpperLimit': '-1.448', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.246', 'groupDescription': 'The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'An ANCOVA model was used for the analysis.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.279', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.152', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.114', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1265', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.185', 'ciUpperLimit': '0.147', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.074', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.199', 'ciUpperLimit': '0.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'An ANCOVA model was used for the analysis.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.579', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.620', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '0.374', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.01', 'ciLowerLimit': '-2.707', 'ciUpperLimit': '0.696', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.868', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.332', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.969', 'ciUpperLimit': '0.665', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.672', 'groupDescription': 'The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \\>8.5%) at Week -1, randomization strata of mean SBP (\\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'An ANCOVA model was used for the analysis.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}, {'value': '54.6', 'groupId': 'OG001'}, {'value': '59.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks', 'description': 'An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs \\[OADs\\]) continued throughout the study.'}, {'id': 'OG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'OG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'classes': [{'title': 'Any hypoglycemia', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}, {'value': '62.8', 'groupId': 'OG002'}]}]}, {'title': 'Documented symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Severe or documented symptomatic hypoglycemia', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 55.7 weeks', 'description': 'Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \\[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\\]; Severe \\[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\\] or documented symptomatic hypoglycemia \\[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomised participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without oral antidiabetes drugs \\[OADs\\]) continued throughout the study.'}, {'id': 'FG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'FG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '286'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '285'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '249'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': "At the Participant's Own Request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Poor Compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 101 investigative sites in the United States, Bulgaria, Canada, Czech Republic, France, Hungary, Slovakia, the United Kingdom from 15 September 2017 to 27 September 2019.', 'preAssignmentDetails': 'Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups, placebo, sotagliflozin 200 milligrams (mg) and sotagliflozin 400 mg. Participants were randomized at a ratio of 1:1:2 respectively to 1 of 3 groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}, {'value': '571', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to receive matching placebo to sotagliflozin 200 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 55.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'BG001', 'title': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 54.7 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'BG002', 'title': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 54.6 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '9.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '481', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '475', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.76', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '8.76', 'spread': '0.83', 'groupId': 'BG001'}, {'value': '8.69', 'spread': '0.80', 'groupId': 'BG002'}, {'value': '8.72', 'spread': '0.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure (SBP)', 'classes': [{'categories': [{'measurements': [{'value': '137.59', 'spread': '14.12', 'groupId': 'BG000'}, {'value': '136.40', 'spread': '15.54', 'groupId': 'BG001'}, {'value': '135.84', 'spread': '14.95', 'groupId': 'BG002'}, {'value': '136.42', 'spread': '14.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter of Mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-12', 'size': 3853301, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-12T09:36', 'hasProtocol': True}, {'date': '2019-12-05', 'size': 1883361, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-12T09:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2020-08-14', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-16', 'studyFirstSubmitDate': '2017-09-14', 'dispFirstSubmitQcDate': '2020-08-14', 'resultsFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2017-09-14', 'dispFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-16', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Hypoglycemic Events', 'timeFrame': 'Up to 55.7 weeks', 'description': 'Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \\[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\\]; Severe \\[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\\] or documented symptomatic hypoglycemia \\[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\\].'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18', 'timeFrame': 'Baseline and Week 18', 'description': 'An analysis of covariance (ANCOVA) model was used for the analysis.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18', 'timeFrame': 'Baseline and Week 18', 'description': 'FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.'}, {'measure': 'Change From Baseline in Body Weight at Week 18', 'timeFrame': 'Baseline and Week 18', 'description': 'An ANCOVA model was used for the analysis.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.'}, {'measure': 'Change From Baseline in SBP at Week 12 for All Participants', 'timeFrame': 'Baseline to Week 12', 'description': 'An ANCOVA model was used for the analysis.'}, {'measure': 'Change From Baseline in HbA1c at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'An ANCOVA model was used for the analysis.'}, {'measure': 'Change From Baseline in Body Weight at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'An ANCOVA model was used for the analysis.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks', 'description': 'An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).\n\nSecondary Objectives:\n\n* To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.\n* To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.\n* To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.', 'detailedDescription': 'Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Participants with Type 2 Diabetes Mellitus (T2DM) using any types of basal insulin alone or in combination with up to 2 OADs.\n* Participants have given written informed consent to participate in the study in accordance with local regulations.\n\nExclusion criteria:\n\n* At the time of Screening age \\<18 years or \\<legal age of majority, whichever is greater.\n* Type 1 diabetes mellitus.\n* Oral antidiabetic drugs dose not stable for 8 weeks before Screening.\n* Use of basal insulin therapy (e.g., insulin glargine, Neutral Protamine Hagedorn (NPH), detemir, or degludec) for less than 6 months before Screening.\n* Dose of basal insulin (e.g., insulin glargine, NPH, detemir, or degludec) not stable for 8 weeks before Screening (i.e., total daily insulin dose increased or decreased by more than 20%).\n* Known unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema that is likely to require laser, surgical treatment during study period.\n* Use of injectable diabetes drugs other than basal insulin (e.g., insulin glargine, NPH, detemir, or degludec), i.e., prandial or rapid-acting insulins, short-acting insulins, glucagon-like peptide 1 (GLP-1) receptor agonists, or inhaled prandial insulin (Afrezza) within 8 weeks of Screening.\n* Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor (e.g., canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the trial.\n* Use of systemic glucocorticoids (excluding topical, intra articular, or ophthalmic application, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.\n* Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.\n* Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.\n* Known presence of factors that interfere with the Central Lab HbA1c measurement (e.g., genetic hemoglobin (Hb) variants) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to randomization, any condition that shortens erythrocyte survival).\n* Participants who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from prior to Screening, whichever is longer.\n* Participants unwilling to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.\n* HbA1c \\<7.5% or HbA1c \\>10.5% measured by the central laboratory at Screening.\n* HbA1c \\<7% measured by the central laboratory at Visit 5 (Week -1).\n* History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.\n* Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.\n* Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.\n* Mean of 3 separate blood pressure measurements \\>180 mmHg (systolic blood pressure \\[SBP\\]) or \\>100 mmHg (diastolic blood pressure \\[DBP\\]).\n* History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 times the upper limit of the normal laboratory range\n* Total bilirubin \\>1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03285594', 'acronym': 'SOTA-INS', 'briefTitle': 'Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)', 'orgStudyIdInfo': {'id': 'EFC14868'}, 'secondaryIdInfos': [{'id': '2016-001804-43', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1190-7567', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'interventionNames': ['Drug: Insulin glargine (HOE901)', 'Drug: Placebo', 'Drug: Oral Antidiabetes Drugs (OADs)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotagliflozin 200 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'interventionNames': ['Drug: Sotagliflozin', 'Drug: Insulin glargine (HOE901)', 'Drug: Placebo', 'Drug: Oral Antidiabetes Drugs (OADs)']}, {'type': 'EXPERIMENTAL', 'label': 'Sotagliflozin 400 mg', 'description': 'Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.', 'interventionNames': ['Drug: Sotagliflozin', 'Drug: Insulin glargine (HOE901)', 'Drug: Oral Antidiabetes Drugs (OADs)']}], 'interventions': [{'name': 'Sotagliflozin', 'type': 'DRUG', 'otherNames': ['SAR439954'], 'description': 'Pharmaceutical form: Tablet\n\nRoute of administration: Oral', 'armGroupLabels': ['Sotagliflozin 200 mg', 'Sotagliflozin 400 mg']}, {'name': 'Insulin glargine (HOE901)', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'Pharmaceutical form: Solution\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Placebo', 'Sotagliflozin 200 mg', 'Sotagliflozin 400 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet\n\nRoute of administration: Oral', 'armGroupLabels': ['Placebo', 'Sotagliflozin 200 mg']}, {'name': 'Oral Antidiabetes Drugs (OADs)', 'type': 'DRUG', 'description': 'OADs (including metformin) as prescribed by the investigator as per local labeling.', 'armGroupLabels': ['Placebo', 'Sotagliflozin 200 mg', 'Sotagliflozin 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213-5226', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8406028', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8406013', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8406020', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8406006', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8406053', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8406040', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406043', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406008', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406030', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406003', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406029', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406052', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406001', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33700', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406022', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406025', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401-3430', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8406002', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60602', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8406054', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60604', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8406027', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8406042', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '70119-6302', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8406044', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70124', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8406051', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 8406024', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8406016', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8406011', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68046-3136', 'city': 'Papillion', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8406010', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '10016-6023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8406018', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406034', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406046', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406026', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406038', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406036', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28401-6638', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406015', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406019', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8406031', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '43201', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8406023', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8406005', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8406004', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '73111', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 8406033', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29461-5017', 'city': 'Moncks Corner', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8406032', 'geoPoint': {'lat': 33.19632, 'lon': -80.01429}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8406009', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37865-5270', 'city': 'Seymour', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8406045', 'geoPoint': {'lat': 35.89064, 'lon': -83.72462}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406047', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406017', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406048', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77099', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406037', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78504', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406039', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406050', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 8406021', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '84102-1553', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8406035', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088-8865', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8406014', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '5300', 'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 1006009', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 1006003', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': 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