Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Condition: Heart Failure; Type 2 Diabetes Mellitus
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sotagliflozin; Placebo
Intervention description: Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1222.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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 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)
    

Eligibility 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 picograms per milliliter (pg/mL) (≥450 pg/mL for
             participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600
             pg/mL (≥1800 pg/mL for participants with atrial fibrillation).

          -  Participants 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 participant'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 milliliter
             per minute per 1.72 meter square (mL/min/1.73 m^2).

          -  Pregnancy.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.