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

Conditions

Diseases of the Cardiovascular System

Phase III

What is the purpose of this trial?

Brief 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.

  • Trial with
    Sanofi
  • Start Date
    06/18/2019
  • End Date
    12/31/2020
Trial Image

For more information about this study, contact:

Lynn Wilson

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If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    06/20/2019
  • Study HIC
    #2000023555