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SCORED: Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

Sponsor
Lexicon Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT03315143
Collaborator
Sanofi (Industry)
10,584
Enrollment
754
Locations
2
Arms
31.3
Actual Duration (Months)
14
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objectives:

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 patients with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

Secondary Objectives:
To compare the effects of sotagliflozin to placebo on:

  • Total occurrences of HHF and urgent visit for HF

  • Occurrences of cardiovascular death

  • Total occurrences of cardiovascular death, HHF, urgent HF visit, non-fatal stroke, and non-fatal myocardial infarction

  • Total occurrences of cardiovascular death, HHF, urgent HF visit, and HF while hospitalized

  • First occurrence of a sustained ≥50% decrease in estimated glomerular filtration rate (eGFR) from baseline (for ≥30 days), chronic dialysis, renal transplant or sustained eGFR <15 mL/min/1.73m2 (for ≥30 days)

  • All-cause mortality

  • Total occurrences of cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction

Condition or Disease Intervention/Treatment Phase
  • Drug: Sotagliflozin (SAR439954)
  • Drug: Placebo
 Phase 3

Detailed Description

Study duration per participant is approximately 27 to 51 months, assuming approximately 24 months of recruitment, and approximately 27 months of follow-up after the last patient is randomized.

Study Design

Study Type:
Interventional
Actual Enrollment :
10584 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Nov 28, 2017
Actual Primary Completion Date :
Jul 8, 2020
Actual Study Completion Date :
Jul 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sotagliflozin

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

Drug: Sotagliflozin (SAR439954)
Pharmaceutical form: tablet Route of administration: oral
Placebo Comparator: Placebo

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

Drug: Placebo
Pharmaceutical form: tablet Route of administration: oral

Outcome Measures

Primary Outcome Measures

  1. Total occurrences of CV Death and Heart Failure Events [Baseline through a maximum of 33 months]

    The primary endpoint is the total occurrences (first and potentially subsequent) of CV death, Hospitalization for Heart Failure (HHF), and urgent HF visits after randomization.

Secondary Outcome Measures

  1. Total occurrences of Heart Failure Events [Baseline through a maximum of 33 months]

    Total occurrences of HHF and urgent HF visits after randomization

  2. CV Death [Baseline through a maximum of 33 months]

    Time to occurrence of CV Death after randomization

  3. Total occurrences of 3-Point MACE plus HHF events [Baseline through a maximum of 33 months]

    Total occurrences of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization

  4. Total occurrences of CV Death, HF Events, and HF while hospitalized [Baseline through a maximum of 33 months]

    Total occurrences of CV Death, HHF, urgent HF Visits, and HF while hospitalized after randomization

  5. Time to composite renal event [Baseline through a maximum of 33 months]

    Time to first occurrence after randomization of the composite of sustained ≥50% decrease in eGFR from baseline (for ≥30 days), chronic dialysis, renal transplant, or sustained eGFR<15 mL/min/1.73m2 (for ≥30 days) in the total patient population

  6. All-Cause Mortality [Baseline through a maximum of 33 months]

    Occurrence of all-cause mortality after randomization

  7. Total occurrences of 3-Point MACE [Baseline through a maximum of 33 months]

    Total occurrences of CV death, non-fatal stroke, and non-fatal myocardial infarction after randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site Number 8400017 Birmingham Alabama United States 35205
2 Investigational Site Number 8400096 Sheffield Alabama United States 35660
3 Investigational Site Number 8400004 Mesa Arizona United States 85206
4 Investigational Site Number 8400059 Mesa Arizona United States 85210
5 Investigational Site Number 8400021 Peoria Arizona United States 85381
6 Investigational Site Number 8400014 Surprise Arizona United States 85374
7 Investigational Site Number 8400071 Little Rock Arkansas United States 72211
8 Investigational Site Number 8400039 Beverly Hills California United States 90211
9 Investigational Site Number 8400042 Concord California United States 94520
10 Investigational Site Number 8400089 Fresno California United States 93720
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12 Investigational Site Number 8400036 Long Beach California United States 90807
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18 Investigational Site Number 8400018 San Dimas California United States 91713
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156 Investigational Site Number 0360016 Heidelberg Australia 3081
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Sponsors and Collaborators

  • Lexicon Pharmaceuticals
  • Sanofi

Investigators

  • Study Director: Suman Wason, MD, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03315143
Other Study ID Numbers:
  • EFC14875
  • 2017-002644-32
  • U1111-1187-8703
First Posted:
Oct 19, 2017
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Study Results

No Results Posted as of Oct 28, 2020