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

• Status: Terminated
• Trial end date: 2020-06-05

Summary

Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable patients after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

• The total occurrences of HHF and urgent visit for HF

• The occurrence of CV death

• The occurrence of all-cause mortality

• The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke

• Change in KCCQ-12 score

• Change in estimated glomerular filtration rate (eGFR)

• Phase: Phase 3

Details

• Lead Sponsor: Lexicon Pharmaceuticals; Sanofi
• Collaborator: Sanofi
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol