Last updated on December 2018

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients With Type 2 Diabetes Moderate Impairment of Kidney Function and Inadequate Blood Sugar Control


Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight
  • To evaluate the safety of sotagliflozin dose 1 and dose 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: NCT03242252

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Trial Transparency email recommended (Toll ...

Investigational Site Number 7104009
Pretoria Gauteng, South Africa
1.95miles

Trial Transparency email recommended (Toll ...

Investigational Site Number 7104006
Pretoria, South Africa
5.43miles

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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