Phase 3Terminated

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

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

Sponsor
Lexicon Pharmaceuticals (Industry)
Enrolment
1,222 enrolled
Conditions
Heart Failure; Type 2 Diabetes Mellitus
Interventions
Sotagliflozin; Placebo
Ages
adults, older adults
Registry
NCT03521934

From the registry

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 participants 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 Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score * Change in estimated glomerular filtration rate (eGFR)

Primary outcomes

  • Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Full record on ClinicalTrials.gov

Papers citing this trial