Trials / Terminated
TerminatedNCT03761134
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Metformin in Combination With Sulfonylurea
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on metformin alone or metformin in combination with sulfonylurea. Secondary Objectives: To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight. * To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight. * To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg. * To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.
Detailed description
Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sotagliflozin (SAR439954) | Pharmaceutical form: tablet Route of administration: oral |
| DRUG | placebo | Pharmaceutical form: tablet Route of administration: oral |
| DRUG | metformin | Pharmaceutical form: tablet Route of administration: oral |
| DRUG | sulfonylurea | Pharmaceutical form: tablet Route of administration: oral |
Timeline
- Start date
- 2018-11-30
- Primary completion
- 2020-04-29
- Completion
- 2020-04-29
- First posted
- 2018-12-03
- Last updated
- 2022-04-25
Locations
40 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03761134. Inclusion in this directory is not an endorsement.