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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Type 2 Diabetes Mellitus

In brief

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)

Key facts

Study ID

NCT03521934

Run by

Lexicon Pharmaceuticals

People needed

1222

Starts

2018-06-15

Expected to finish

2020-06-05

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8400109 — Cottonwood, Arizona, United States
• Investigational Site Number 8400032 — Little Rock, Arkansas, United States
• Investigational Site Number 8400080 — Little Rock, Arkansas, United States
• Investigational Site Number 8400075 — Bakersfield, California, United States
• Investigational Site Number 8400069 — Fresno, California, United States
• Investigational Site Number 8400008 — Los Angeles, California, United States
• Investigational Site Number 8400063 — Los Angeles, California, United States
• Investigational Site Number 8400127 — National City, California, United States
• Investigational Site Number 8400007 — Redondo Beach, California, United States
• Investigational Site Number 8400036 — Stockton, California, United States
• Investigational Site Number 8400033 — Sylmar, California, United States
• Investigational Site Number 8400049 — Torrance, California, United States
• Investigational Site Number 8400028 — Walnut Creek, California, United States
• Investigational Site Number 8400029 — Bridgeport, Connecticut, United States
• Investigational Site Number 8400037 — New Haven, Connecticut, United States
• Investigational Site Number 8400046 — DeLand, Florida, United States
• Investigational Site Number 8400009 — Gainesville, Florida, United States
• Investigational Site Number 8400079 — Homestead, Florida, United States
• Investigational Site Number 8400031 — Jacksonville, Florida, United States
• Investigational Site Number 8400022 — Jacksonville, Florida, United States
• Investigational Site Number 8400098 — Lake Mary, Florida, United States
• Investigational Site Number 8400058 — Miami Beach, Florida, United States
• Investigational Site Number 8400105 — Orlando, Florida, United States
• Investigational Site Number 8400082 — Pensacola, Florida, United States
• Investigational Site Number 8400128 — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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