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Clinical Trial Summary

Primary Objective:

- To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF).

- To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF.

Secondary Objectives:

- To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events:

- Cardiovascular death, HHF or urgent HF visit.

- To demonstrate that, when compared to placebo, sotagliflozin reduces:

- The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population.

- Cardiovascular death in patients with LVEF < 50%.

- Cardiovascular death in the total patient population.

- All-cause mortality in patients with LVEF < 50%.

- All cause mortality in the total patient population.

- To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.


Clinical Trial Description

The estimated study duration for a given patient will be approximately 3 to 32 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03521934
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 June 11, 2018
Completion date January 2021