Last updated on September 2018

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients 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 patients with baseline SBP 130 mmHg;
  • Change from baseline in SBP for all patients;
  • Change from baseline in body weight;
  • Proportion of patients with HbA1c <6.5% and <7.0%.
  • To evaluate the safety of sotagliflozin versus placebo.

Detailed Study Description

The duration of the study period is up to 87 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2 week single blind Run-in phase, a 26 week double-blind Core Treatment Period, a 53-week double-blind Extension Period, a 4 week post treatment Follow-up period to collect safety information.

Clinical Study Identifier: NCT02926950

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Investigational Site Number 8402032
Salt Lake City, UT United States
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