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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03315143




Registration number
NCT03315143
Ethics application status
Date submitted
16/10/2017
Date registered
19/10/2017
Date last updated
28/10/2022

Titles & IDs
Public title
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants 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:
Heart Failure 0 0
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
Treatment: Drugs - Placebo

Experimental: Sotagliflozin - Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.

Placebo Comparator: Placebo - Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.


Treatment: Drugs: Sotagliflozin
Sotagliflozin was administered as a tablet(s), orally once daily.

Treatment: Drugs: Placebo
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
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 30 months
Secondary outcome [1] 0 0
Total Number of Occurrences of HHF and Urgent HF Visits
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Number of Deaths From Cardiovascular Causes
Timepoint [2] 0 0
Up to 30 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 30 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 30 months
Secondary outcome [5] 0 0
Number of Occurrences After Randomization of the Composite of Sustained =50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for =30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for =30 Days)
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Number of Deaths From Any Cause
Timepoint [6] 0 0
Up to 30 months
Secondary outcome [7] 0 0
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Timepoint [7] 0 0
Up to 30 months

Eligibility
Key inclusion criteria
Inclusion criteria :

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

- Estimated glomerular filtration rate (eGFR) =25 and =60 milliliter/minute
(mL/min)/1.73 square meter (m^2).

- 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
Sex
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
participant'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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/07/2020
Sample size
Target
Accrual to date
Final
10584
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
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Investigational Site Number 0360009 - Liverpool
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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
Recruitment postcode(s) [7] 0 0
2250 - Gosford
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3081 - Heidelberg
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4029 - Herston
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2170 - Liverpool
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
2291 - Merewether
Recruitment postcode(s) [13] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
4020 - Redcliffe
Recruitment postcode(s) [16] 0 0
4075 - Sherwood
Recruitment postcode(s) [17] 0 0
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
The primary objective of the study was to compare the effect of sotagliflozin to placebo on
total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and
urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk
factors, and moderate to severely impaired renal function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03315143
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03315143