Last updated on July 2018

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy


Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.

Secondary Objectives:

  • To compare sotagliflozin dose 1 versus placebo based on:
  • 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%, <7.0%.
  • To compare sotagliflozin dose 2 versus placebo based on:
  • Change from baseline in HbA1c
  • Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;
  • Change from baseline in body weight;
  • Change from baseline in SBP for all patients.
  • To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.

Detailed Study Description

Up to 34 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 26-week double-blind Treatment Period, and a 4-week post-treatment Follow-up visit to collect safety information.

Clinical Study Identifier: NCT02926937

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Investigational Site Number 8401024
Bradenton, FL United States
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