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Heart Failure-Type 2 Diabetes Mellitus clinical trials

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NCT ID: NCT03521934 Not yet recruiting - Clinical trials for Heart Failure-Type 2 Diabetes Mellitus

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

Start date: June 14, 2018
Phase: Phase 3
Study type: Interventional

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.