Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Subjects With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

  • STATUS
    Not Recruiting
  • participants needed
    930
  • sponsor
    Sanofi
Updated on 16 May 2021
Investigational Site Number 8407121 (0.0 mi away) Contact
metformin
hypoglycemic agents
glimepiride

Summary

Primary Objective:

To demonstrate the non-inferiority of sotagliflozin dose 1 compared to glimepiride on HbA1c (glycosylated A1c) reduction in patients with T2D (type 2 diabetes) who have inadequate glycemic control with metformin.

Secondary Objectives:

To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in body weight, SBP (systolic blood pressure) in patients with baseline SBP 130 mmHg, SBP in all patients, and proportion of patients with at least 1 documented symptomatic hypoglycemic event (70 mg/dL).

  • To demonstrate the superiority of sotagliflozin dose 1 compared to placebo on change in HbA1c, body weight, SBP in patients with baseline SBP 130 mmHg, SBP in all patients.
  • To demonstrate the superiority of sotagliflozin dose 2 compared to placebo on change in HbA1c.
  • To demonstrate the non-inferiority of sotagliflozin dose 2 compared to glimepiride on change in HbA1c.
  • To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in HbA1c.
  • To evaluate the safety and tolerability of sotagliflozin compared to glimepiride and placebo.

Description

Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.

Details
Condition NIDDM
Treatment Placebo, Metformin, Glimepiride, Sotagliflozin (SAR439954)
Clinical Study IdentifierNCT03332771
SponsorSanofi
Last Modified on16 May 2021

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