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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03315143




Registration number
NCT03315143
Ethics application status
Date submitted
16/10/2017
Date registered
19/10/2017
Date last updated
24/02/2020

Titles & IDs
Public title
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
Secondary ID [1] 0 0
2017-002644-32
Secondary ID [2] 0 0
EFC14875
Universal Trial Number (UTN)
Trial acronym
SCORED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Chronic Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin (SAR439954)
Treatment: Drugs - Placebo

Experimental: Sotagliflozin - Sotagliflozin dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)

Placebo Comparator: Placebo - Placebo dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)


Treatment: Drugs: Sotagliflozin (SAR439954)
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
Time to first Major Adverse Cardiovascular Event (MACE) - Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke
Timepoint [1] 0 0
Baseline to approximately 51 months
Primary outcome [2] 0 0
Time to cardiovascular death or hospitalization for heart failure - Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure
Timepoint [2] 0 0
Baseline to approximately 51 months
Secondary outcome [1] 0 0
Time to first composite renal event - Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days)
Timepoint [1] 0 0
Baseline to approximately 51 months
Secondary outcome [2] 0 0
Time to first composite renal event in subgroup of patients with macroalbuminuria - Time to the first occurrence of any of the following clinical events in patients with baseline eGFR =30 mL/min/1.73 m2 and baseline UACR =300 mg/g: Sustained =50% decrease of eGFR from baseline (for =30 days); chronic dialysis, renal transplant or sustained eGFR <15 ml/min/1.73 m2 (for =30 days
Timepoint [2] 0 0
Baseline to approximately 51 months
Secondary outcome [3] 0 0
Total number of heart failure events - Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit
Timepoint [3] 0 0
Baseline to approximately 51 months
Secondary outcome [4] 0 0
Cardiovascular (CV) death - Time to CV death
Timepoint [4] 0 0
Baseline to approximately 51 months
Secondary outcome [5] 0 0
All cause mortality - Time to all-cause mortality
Timepoint [5] 0 0
Baseline to approximately 51 months

Eligibility
Key inclusion criteria
Inclusion criteria :

- Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) = 7%.

- Estimated glomerular filtration rate (eGFR) = 25 and = 60 mL/min/1.73 m2.

- Age 18 years or older with at least one major cardiovascular risk factor or age 55
years or older with at least two minor cardiovascular risk factors.

- Signed written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.

- Planned coronary procedure or surgery after randomization.

- 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.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.

Study design
Purpose of the study
Prevention
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0360014 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 0360004 - Box Hill
Recruitment hospital [3] 0 0
Investigational Site Number 0360015 - Elizabeth Vale
Recruitment hospital [4] 0 0
Investigational Site Number 0360005 - Fitzroy
Recruitment hospital [5] 0 0
Investigational Site Number 0360018 - Fremantle
Recruitment hospital [6] 0 0
Investigational Site Number 0360007 - Fullarton
Recruitment hospital [7] 0 0
Investigational Site Number 0360002 - Gosford
Recruitment hospital [8] 0 0
Investigational Site Number 0360016 - Heidelberg
Recruitment hospital [9] 0 0
Investigational Site Number 0360010 - Herston
Recruitment hospital [10] 0 0
Investigational Site Number 0360009 - Liverpool
Recruitment hospital [11] 0 0
Investigational Site Number 0360017 - Melbourne
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Investigational Site Number 0360001 - Merewether
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Investigational Site Number 0360012 - Oaklands Park
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Investigational Site Number 0360011 - Parkville
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Investigational Site Number 0360008 - Redcliffe
Recruitment hospital [16] 0 0
Investigational Site Number 0360013 - Sherwood
Recruitment hospital [17] 0 0
Investigational Site Number 0360019 - St Leonards
Recruitment hospital [18] 0 0
Investigational Site Number 0360006 - Wollongong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 0 0
5063 - Fullarton
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2250 - Gosford
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3081 - Heidelberg
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4029 - Herston
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2170 - Liverpool
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3004 - Melbourne
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2291 - Merewether
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5046 - Oaklands Park
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3050 - Parkville
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4020 - Redcliffe
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4075 - Sherwood
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2065 - St Leonards
Recruitment postcode(s) [18] 0 0
2500 - Wollongong
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Swansea

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
Primary Objectives:

To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D),
cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:

- Does not increase the risk of cardiovascular events including death from cardiovascular
disease, non-fatal heart attack and non-fatal stroke;

- Reduces the risk of death from CV disease or hospitalization for heart failure.

Secondary Objectives:

- To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and
moderately impaired renal function, sotagliflozin:

- Reduces cardiovascular events including death from cardiovascular disease, non-fatal
heart attack and non-fatal stroke;

- Reduces risk of progression of kidney disease;

- Reduces cardiovascular events including death from cardiovascular disease and emergency
treatment for heart failure;

- Reduces death from cardiovascular disease;

- Reduces death from any cause.

- To assess the safety and tolerability of sotagliflozin.
Trial website
https://clinicaltrials.gov/show/NCT03315143
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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

Summary results
Other publications