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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521934
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Heart Failure-Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

Detailed Description:
The estimated study duration for a given patient will be approximately 3 to 32 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sotagliflozin
Sotagliflozin dose 1, once daily with possible uptitration in the first 8 months to dose 2
 Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral
Placebo Comparator: Placebo
Placebo dose 1, once daily with possible uptitration in the first 8 months to dose 2
 Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with left ventricular ejection fraction (LVEF) <50%

  2. Cardiovascular (CV) death or hospitalization for heart failure (HHF) [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of either CV death or HHF in the total patient population -


Secondary Outcome Measures :
  1. Total number of heart failure events [ Time Frame: Baseline to approximately 32 months ]
    Total number (i.e., including recurrent events) of the following clinical events in the total patient population: Cardiovascular death, Hospitalization for heart failure, Urgent HF visit

  2. Time to first composite renal event [ Time Frame: Baseline to approximately 32 months ]
    Time to first occurrence of the composite of positively adjudicated sustained ≥50% decrease in eGFR from Baseline (for ≥30 days), chronic dialysis, renal transplant, or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 (for ≥30 days) in the total patient population.

  3. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in patients with LVEF <50%

  4. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in the total patient population

  5. All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in patients with LVEF <50%

  6. All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in the total patient population


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521934


Locations
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Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Sangeeta Sawhney, MD Lexicon Pharmaceuticals, Inc.
More Information
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03521934    
Other Study ID Numbers: EFC15156
2017-003510-16 ( EudraCT Number )
U1111-1190-7891 ( Other Identifier: UTN )
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
 Cardiovascular Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs