Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
Status:
Completed
Trial end date:
2019-03-22
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c)
reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control
with metformin.
Secondary Objectives:
- To compare Sotagliflozin versus placebo for.
- Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
- Change from baseline in fasting plasma glucose (FPG).
- Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP
≥130 millimeter of mercury (mmHg).
- Change from baseline in SBP for all participants.
- Change from baseline in body weight.
- Proportion of participants with HbA1c <6.5% and <7.0%.
- To evaluate the safety of Sotagliflozin versus placebo.