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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03521934
• Date of registration: 30/04/2018
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals
• Public title: Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
• Scientific title: 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
• Date of first enrolment: June 11, 2018
• Target sample size: 1222
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03521934
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Suman Wason, MD
• Affiliation: Lexicon Pharmaceuticals, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: Sotagliflozin (SAR439954)

Primary Outcome(s)

Total occurrences of CV Death and Heart Failure Events [Time Frame: Baseline through a maximum of 22.3 months]

Secondary Outcome(s)

Total occurrences of 3-Point MACE plus HHF [Time Frame: Baseline through a maximum of 22.3 months]

Change in Kansas City Cardiomyopathy Questionnaire- 12 (KCCQ-12) Scores [Time Frame: Baseline through a maximum of 22.3 months]

All-Cause Mortality [Time Frame: Baseline through a maximum of 22.3 months]

Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) [Time Frame: Baseline through a maximum of 22.3 months]

Time to CV Death [Time Frame: Baseline through a maximum of 22.3 months]

Total occurrences of CV Death, Heart Failure Events, and HF while hospitalized [Time Frame: Baseline through a maximum of 22.3 months]

Total occurrences of Heart Failure Events [Time Frame: Baseline through a maximum of 22.3 months]

Secondary ID(s)

U1111-1190-7891

2017-003510-16

EFC15156

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi