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Clinical Trial Details

Trial ID: L1786
Source ID: NCT03760965
Associated Drug: Sotagliflozin (Sar439954)
Title: Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sotagliflozin (SAR439954)|DRUG: placebo
Outcome Measures: Primary: Change in hemoglobin A1c (HbA1c), Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1), 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 dose1 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 dose1 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 patients with baseline SBP ≥130 mmHg (for sotagliflozin dose1 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: 276
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-11-27
Completion Date: 2020-04-24
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 1560001, Beijing, 100044, China|Investigational Site Number 1560003, Beijing, 100730, China|Investigational Site Number 1560004, Beijing, 100730, China|Investigational Site Number 1560002, Beijing, 101200, China|Investigational Site Number 1560007, Changchun, 130021, China|Investigational Site Number 1560008, Changchun, 130041, China|Investigational Site Number 1560024, Chongqing, 400010, China|Investigational Site Number 1560022, Guangzhou, 510120, China|Investigational Site Number 1560033, Guangzhou, 510150, China|Investigational Site Number 1560021, Guangzhou, China|Investigational Site Number 1560029, Harbin, 150001, China|Investigational Site Number 1560009, Hohhot, 010017, China|Investigational Site Number 1560014, Huai'An, 223300, China|Investigational Site Number 1560019, Huzhou, China|Investigational Site Number 1560025, Jining, China|Investigational Site Number 1560027, Jining, China|Investigational Site Number 1560012, Luoyang, China|Investigational Site Number 1560013, Pingxiang, 337055, China|Investigational Site Number 1560034, Qingdao, 266011, China|Investigational Site Number 1560026, Qingdao, 266042, China|Investigational Site Number 1560017, Shanghai, 200040, China|Investigational Site Number 1560016, Shanghai, China|Investigational Site Number 1560006, Shijiazhuang, China|Investigational Site Number 1560005, Tianjin, 300211, China|Investigational Site Number 1560035, Wuhan, 430000, China|Investigational Site Number 1560023, Xuzhou, 221006, China|Investigational Site Number 1560028, Yinchuan, 750004, China|Investigational Site Number 1560032, Yuncheng, 044000, China|Investigational Site Number 1560015, Zhuzhou, 412007, China
URL: https://clinicaltrials.gov/show/NCT03760965