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

Status:	Recruiting
Conditions:	Cardiology, Diabetes, Diabetes
Therapuetic Areas:	Cardiology / Vascular Diseases, Endocrinology
Healthy:	No
Age Range:	18 - 85
Updated:	3/27/2019
Start Date:	June 11, 2018
End Date:	January 2021
Contact:	Trial Transparency email recommended (Toll free number for US & Canada)
Email:	Contact-Us@sanofi.com
Phone:	800-633-1610

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

Primary Objective:

- To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity
(composite of CV death or hospitalization for heart failure [HHF]) compared to placebo
in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF)
with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart
failure (WHF).

- To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity
(composite of CV death or hospitalization for heart failure [HHF]) compared to placebo
in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission
for WHF.

Secondary Objectives:

- To demonstrate that, when compared to placebo in the toal patient population,
sotagliflozin reduces the total number (i.e., including recurrent events) of the
following clinical events:

- Cardiovascular death, HHF or urgent HF visit.

- To demonstrate that, when compared to placebo, sotagliflozin reduces:

- The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic
dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2
in the total patient population.

- Cardiovascular death in patients with LVEF < 50%.

- Cardiovascular death in the total patient population.

- All-cause mortality in patients with LVEF < 50%.

- All cause mortality in the total patient population.

- To demonstrate the safety and tolerability of sotagliflozin in the total population in
this study.

The estimated study duration for a given patient will be approximately 3 to 32 months.

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.

We found this trial at

sites

Clinical Trial Facility in Greensboro North Carolina

Greensboro, North Carolina 27401

from

Greensboro, NC