Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-28 @ 2:15 PM
Study NCT ID:
NCT02531035
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 1) to 30 days after end of treatment (Up to 28 Weeks)', 'description': 'Analysis performed on safety population which includes participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.', 'otherNumAtRisk': 703, 'deathsNumAtRisk': 703, 'otherNumAffected': 70, 'seriousNumAtRisk': 703, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.', 'otherNumAtRisk': 699, 'deathsNumAtRisk': 699, 'otherNumAffected': 70, 'seriousNumAtRisk': 699, 'deathsNumAffected': 1, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 41, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 62, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 46, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood ketone body increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urine ketone body present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Encephalomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aural polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mesenteric panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 703, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'OG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '8.97', 'ciUpperLimit': '17.81', 'pValueComment': 'P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\\<25 kg/m\\^2,\\>=25 kg/m\\^2),Week -2 A1C(\\<=9.0%, \\>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \\<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the modified Intent-to-Treat (mITT) population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in A1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '628', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'OG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.38', 'groupDescription': 'Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\\<25 kg/m\\^2, \\>=25 kg/m\\^2), randomization stratum of Week -2 A1C (\\<=9.0%, \\>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.', 'unitOfMeasure': 'percentage of A1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses included participants from the mITT population. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'OG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.122', 'groupId': 'OG000'}, {'value': '-2.21', 'spread': '0.122', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.98', 'ciLowerLimit': '-3.31', 'ciUpperLimit': '-2.66', 'groupDescription': 'Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\\<25 kg/m\\^2, \\>=25 kg/m\\^2), randomization stratum of Week -2 A1C (\\<=9%, \\>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses included participants from the mITT population. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'OG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '-1.3', 'groupDescription': 'Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\\<25 kg/m2, \\>=25 kg/m2), randomization stratum of Week -2 A1C (\\<=9.0%, \\>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from mITT population and who had a Baseline SBP \\>= 130 mm Hg. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Mean Daily Bolus Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'OG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.62', 'spread': '2.272', 'groupId': 'OG000'}, {'value': '-5.71', 'spread': '2.289', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.32', 'ciLowerLimit': '-18.17', 'ciUpperLimit': '-6.48', 'groupDescription': 'Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\\<25 kg/m2, \\>=25 kg/m2), randomization stratum of Week -2 A1C (\\<=9.0%, \\>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.', 'unitOfMeasure': 'percent change in IU/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses included participants from the mITT population. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'FG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '705'}, {'groupId': 'FG001', 'numSubjects': '700'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '703'}, {'groupId': 'FG001', 'numSubjects': '699'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '624'}, {'groupId': 'FG001', 'numSubjects': '605'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '95'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Randomized, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 133 investigative sites across 19 countries: Poland, Slovakia, Spain, United Kingdom, Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Argentina, Australia, Canada, Colombia, Israel, New Zealand, South Africa and United States from 18 September 2015 to 18 April 2017.', 'preAssignmentDetails': '1405 participants with a diagnosis of Type 1 Diabetes were enrolled equally in 1 of 2 treatment groups: placebo or sotagliflozin 400 milligrams (mg).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'BG001', 'title': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.4', 'spread': '14.04', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '14.17', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '14.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '705', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '697', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '621', 'groupId': 'BG000'}, {'value': '619', 'groupId': 'BG001'}, {'value': '1240', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'hemoglobin A1C (A1C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1400', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.21', 'spread': '0.921', 'groupId': 'BG000'}, {'value': '8.26', 'spread': '0.965', 'groupId': 'BG001'}, {'value': '8.23', 'spread': '0.943', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of A1C', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A1C is the measurement of hemoglobin A1C. Data is available for 701 participants in the Placebo arm and 699 participants in the Sotagliflozin arm.'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81.55', 'spread': '17.032', 'groupId': 'BG000'}, {'value': '82.40', 'spread': '17.131', 'groupId': 'BG001'}, {'value': '81.97', 'spread': '17.081', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '12.07', 'groupId': 'BG000'}, {'value': '20.5', 'spread': '12.37', 'groupId': 'BG001'}, {'value': '20.0', 'spread': '12.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Total Daily Insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.291', 'groupId': 'BG000'}, {'value': '0.69', 'spread': '0.276', 'groupId': 'BG001'}, {'value': '0.70', 'spread': '0.284', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'International units per kilogram (IU/kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '1402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.10', 'spread': '5.183', 'groupId': 'BG000'}, {'value': '28.29', 'spread': '5.128', 'groupId': 'BG001'}, {'value': '28.19', 'spread': '5.155', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2 (kilogram(s)/square meter)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis was performed on modified Intent-to-treat (mITT) population included all randomly assigned participants who had taken at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-16', 'size': 1221844, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-08T06:27', 'hasProtocol': True}, {'date': '2017-03-29', 'size': 1570362, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-08T06:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2017-10-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2015-08-20', 'dispFirstSubmitQcDate': '2017-10-16', 'resultsFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2015-08-20', 'dispFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-15', 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization', 'timeFrame': 'Week 24', 'description': 'The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \\<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in A1C', 'timeFrame': 'Baseline to Week 24', 'description': 'Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.'}, {'measure': 'Absolute Change From Baseline in Body Weight', 'timeFrame': 'Baseline to Week 24', 'description': 'Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)', 'timeFrame': 'Baseline to Week 16', 'description': "An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16."}, {'measure': 'Percent Change From Baseline in Mean Daily Bolus Insulin Dose', 'timeFrame': 'Baseline to Week 24', 'description': 'The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus (T1DM)', 'High Level of Sugar (Glucose) in the Blood']}, 'referencesModule': {'references': [{'pmid': '28899222', 'type': 'DERIVED', 'citation': 'Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants had given written informed consent to participate in the study in accordance with local regulations\n* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent\n* Participants were being treated with insulin or insulin analog\n* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol\n* At the Screening Visit, A1C was between 7.0% to 11.0%\n* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test\n\nExclusion Criteria:\n\n* Use of antidiabetic agent other than insulin or insulin analog at the time of screening\n* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening\n* Chronic systemic corticosteroid use\n* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator'}, 'identificationModule': {'nctId': 'NCT02531035', 'acronym': 'inTandem3', 'briefTitle': 'A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'LX4211.1-312-T1DM'}, 'secondaryIdInfos': [{'id': 'LX4211.312', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sotagliflozin 400 mg', 'description': 'Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.', 'interventionNames': ['Drug: Sotagliflozin']}], 'interventions': [{'name': 'Sotagliflozin', 'type': 'DRUG', 'otherNames': ['LX4211'], 'description': 'Sotagliflozin, once daily, before the first meal of the day', 'armGroupLabels': ['Sotagliflozin 400 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, once daily, before the first meal of the day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 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