Last updated on January 2019

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure


Brief description of study

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 Study Identifier: TX217862

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University of South Florida-Morsani College of Medicine

2 Tampa General Circle Tampa, FL United States
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Recruitment Status: Open


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