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

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ClinicalTrials.gov Identifier: NCT03521934
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • 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%
  • 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 -
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03521934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • 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
  • 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.
  • Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in patients with LVEF <50%
  • Cardiovascular (CV) death [ Time Frame: Baseline to approximately 32 months ]
    Time to CV death in the total patient population
  • All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in patients with LVEF <50%
  • All cause mortality [ Time Frame: Baseline to approximately 32 months ]
    Time to all-cause mortality in the total patient population
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Official Title  ICMJE 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
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.
Detailed Description The estimated study duration for a given patient will be approximately 3 to 32 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure-Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sotagliflozin (SAR439954)

    Pharmaceutical form: tablet

    Route of administration: oral

  • Drug: Placebo

    Pharmaceutical form: tablet

    Route of administration: oral

Study Arms  ICMJE
  • Experimental: Sotagliflozin
    Sotagliflozin dose 1, once daily with possible uptitration in the first 8 months to dose 2
    Intervention: Drug: Sotagliflozin (SAR439954)
  • Placebo Comparator: Placebo
    Placebo dose 1, once daily with possible uptitration in the first 8 months to dose 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Poland,   Portugal,   Romania,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521934
Other Study ID Numbers  ICMJE EFC15156
2017-003510-16 ( EudraCT Number )
U1111-1190-7891 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP