Last updated on November 2018

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

Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control with a sulfonylurea alone or in combination with metformin.

Secondary Objectives:

  • To compare sotagliflozin 400 mg versus placebo based on:
  • Change from baseline in fasting plasma glucose (FPG).
  • Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP 130 mm Hg.
  • 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 400 mg versus placebo throughout the 79-week trial.

Detailed Study Description

The duration per patient is up to 85 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, and a 2-week post treatment Follow-up period to collect safety information.

Clinical Study Identifier: NCT03066830

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Investigational Site Number 8403001
Northglenn, CO United States