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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion criteria:

• Type 2 Diabetes Mellitus.

• Admitted to the hospital, or urgent heart failure visit for worsening heart failure.

• Prior diagnosis of heart failure (> 3 months).

• Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days.

• Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.

• Brain natriuretic peptide (BNP) ≥150 pg/mL (≥450 pg/mL for patients with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for patients with atrial fibrillation).

• Patients with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.

• Signed written informed consent.

Exclusion criteria:

• Age < 18 years or > 85 years.

• Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.

• Cardiac surgery or coronary procedure within 1 month or planned during study.

• Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.

• Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.

• Acute coronary syndromes within 3 months prior to Randomization.

• Hemodynamically significant uncorrected primary valvular disease.

• Significant pulmonary disease contributing substantially to the patient's dyspnea.

• End stage Heart Failure.

• History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.

• History of stroke within 3 months prior to randomization.

• History of dialysis within 1 year prior to randomization.

• History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).

• Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 mL/min/1.73 m².

• Pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.