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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315143
Recruitment Status : Terminated (study terminated prematurely for financial reasons and Covid-19 pandemic)
First Posted : October 19, 2017
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Description
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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
Type 2 Diabetes Mellitus Chronic Kidney Diseases 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
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Study Type : Interventional  (Clinical Trial)
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 : November 28, 2017
Actual Primary Completion Date : July 8, 2020
Actual Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Total occurrences of CV Death and Heart Failure Events [ Time Frame: 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 [ Time Frame: Baseline through a maximum of 33 months ]
    Total occurrences of HHF and urgent HF visits after randomization

  2. CV Death [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline through a maximum of 33 months ]
    Occurrence of all-cause mortality after randomization

  7. Total occurrences of 3-Point MACE [ Time Frame: Baseline through a maximum of 33 months ]
    Total occurrences of CV death, non-fatal stroke, and non-fatal myocardial infarction after randomization


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315143


Locations
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Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03315143    
Other Study ID Numbers: EFC14875
2017-002644-32
U1111-1187-8703 ( Other Identifier: UTN )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Renal Insufficiency
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs