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Clinical Trial Summary

Primary Objectives:

To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:

- Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;

- Reduces the risk of death from CV disease or hospitalization for heart failure.

Secondary Objectives:

- To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin:

- Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke;

- Reduces risk of progression of kidney disease;

- Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure;

- Reduces death from cardiovascular disease;

- Reduces death from any cause.

- To assess the safety and tolerability of sotagliflozin.


Clinical Trial Description

Study duration per participant is approximately 27 to 51 months, assuming approximately 24 months of recruitment, and approximately 27 months of follow-up after the last patient is randomized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03315143
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-Us@sanofi.com
Status Recruiting
Phase Phase 3
Start date November 28, 2017
Completion date March 2022

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