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Clinical Trial Details

Trial ID: L4160
Source ID: NCT03761134
Associated Drug: Sotagliflozin (Sar439954)
Title: Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sotagliflozin (SAR439954)|DRUG: placebo|DRUG: metformin|DRUG: sulfonylurea
Outcome Measures: Primary: Change in hemoglobin A1c (HbA1c), Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1), Baseline to Week 24 | Secondary: Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2), Baseline to Week 24|Change in fasting plasma glucose (FPG), Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2), Baseline to Week 24|Change in body weight, Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2), Baseline to Week 24|Change in HbA1c, Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2), Baseline to Week 24|Change in systolic blood pressure (SBP) for all patients, Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2), Baseline to Week 12|Change in SBP for patients with baseline SBP ≥130 mmHg, Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2), Baseline to Week 12|Adverse events, Number of patients with adverse events, Up to Week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 377
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-11-30
Completion Date: 2020-04-29
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 1560039, Baotou, 014010, China|Investigational Site Number 1560040, Baotou, 014010, China|Investigational Site Number 1560001, Beijing, 100029, China|Investigational Site Number 1560038, Beijing, 100191, China|Investigational Site Number 1560035, Cangzhou, 061000, China|Investigational Site Number 1560020, Changchun, 130033, China|Investigational Site Number 1560012, Changchun, 130041, China|Investigational Site Number 1560011, Changsha, 410011, China|Investigational Site Number 1560021, Changzhou, 213003, China|Investigational Site Number 1560024, Chongqing, 400010, China|Investigational Site Number 1560028, Dalian, 116011, China|Investigational Site Number 1560010, Dalian, 116033, China|Investigational Site Number 1560036, Dalian, China|Investigational Site Number 1560030, Fuzhou, 354200, China|Investigational Site Number 1560032, Guangzhou, 510080, China|Investigational Site Number 1560027, Guangzhou, 510180, China|Investigational Site Number 1560041, Hangzhou, China|Investigational Site Number 1560046, Harbin, 150001, China|Investigational Site Number 1560009, Hefei, 230001, China|Investigational Site Number 1560025, Hohhot, 010017, China|Investigational Site Number 1560026, Huai'An, 223300, China|Investigational Site Number 1560006, Jinan, 250013, China|Investigational Site Number 1560033, Kunming, China|Investigational Site Number 1560034, Luoyang, China|Investigational Site Number 1560014, Nanjing, 210011, China|Investigational Site Number 1560018, Pingxiang, 337055, China|Investigational Site Number 1560003, Shanghai, 200072, China|Investigational Site Number 1560004, Shanghai, 201700, China|Investigational Site Number 1560013, Shanghai, China|Investigational Site Number 1560005, Shenyang, 110004, China|Investigational Site Number 1560019, Shijiazhuang, China|Investigational Site Number 1560017, Suzhou, 215004, China|Investigational Site Number 1560022, Wuhan, 430014, China|Investigational Site Number 1560023, Wuxi, 214023, China|Investigational Site Number 1560015, Xiangtan, China|Investigational Site Number 1560043, Yuncheng, 044000, China|Investigational Site Number 1560042, Zhengzhou, 450003, China|Investigational Site Number 1560007, Zhenjiang, 212001, China|Investigational Site Number 1560037, Zhongshan, China|Investigational Site Number 1560016, Zhuzhou, 412007, China
URL: https://clinicaltrials.gov/show/NCT03761134

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details