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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03521934




Registration number
NCT03521934
Ethics application status
Date submitted
30/04/2018
Date registered
11/05/2018

Titles & IDs
Public title
Effect of Sotagliflozin on Cardiovascular Events in Participants 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
Secondary ID [1] 0 0
2017-003510-16
Secondary ID [2] 0 0
EFC15156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin
Treatment: Drugs - Placebo

Experimental: Sotagliflozin - Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.

Placebo comparator: Placebo - Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.


Treatment: Drugs: Sotagliflozin
Pharmaceutical form: tablet

Route of administration: oral

Treatment: Drugs: Placebo
Pharmaceutical form: tablet

Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Timepoint [1] 0 0
Up to 21.9 months
Secondary outcome [1] 0 0
Total Number of Occurrences of HHF and Urgent HF Visits
Timepoint [1] 0 0
Up to 21.9 months
Secondary outcome [2] 0 0
Total Number of Deaths From Cardiovascular Causes
Timepoint [2] 0 0
Up to 21.9 months
Secondary outcome [3] 0 0
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [3] 0 0
Up to 21.9 months
Secondary outcome [4] 0 0
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Timepoint [4] 0 0
Up to 21.9 months
Secondary outcome [5] 0 0
Total Number of Deaths From Any Cause
Timepoint [5] 0 0
Up to 21.9 months
Secondary outcome [6] 0 0
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
Timepoint [6] 0 0
Baseline to Month 4
Secondary outcome [7] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [7] 0 0
Baseline up to 21.9 months

Eligibility
Key inclusion 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 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/06/2020
Sample size
Target
Accrual to date
Final
1222
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0360007 - Murdoch
Recruitment hospital [2] 0 0
Investigational Site Number 0360001 - Wollongong
Recruitment postcode(s) [1] 0 0
6150 - Murdoch
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
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Auckland
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lexicon Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suman Wason, MD
Address 0 0
Lexicon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03521934