Last updated on August 2018

A Study to Evaluate Safety and Effects of Sotagliflozin Dose 1 and Dose 2 on Glucose Control in Patients With Type 2 Diabetes Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to hemoglobin A1c (HbA1c) reduction in patients with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 2 versus placebo based on change from baseline in HbA1c
  • To assess the effects of sotagloflozin doses 1 and 2 versus placebo
  • To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo

Detailed Study Description

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Clinical Study Identifier: NCT03242018

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Investigational Site Number 8405006
Ocoee, FL United States
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