Last updated on November 2018

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

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Investigational Site Number 8406003
New Port Richey, FL United States