Last updated on November 2019

Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

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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.

Detailed Study Description

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