Last updated on May 2019

Efficacy and Safety of Sotagliflozin Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose (FPG), body weight, Systolic Blood Pressure (SBP), and HbA1c.
  • To assess the effects of sotagliflozin dose 2 versus placebo on HbA1c, body weight, FPG, and SBP.
  • To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.

Detailed Study Description

Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.

Clinical Study Identifier: NCT03285594

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.