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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)

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ClinicalTrials.gov Identifier: NCT03315143
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10500 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
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Time to first Major Adverse Cardiovascular Event (MACE) [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death, Non-fatal myocardial infarction (MI), Non-fatal stroke

  2. Time to cardiovascular death or hospitalization for heart failure [ Time Frame: Baseline to approximately 51 months ]
    Time to the first occurrence of any of the following clinical events: Cardiovascular death; Hospitalization for heart failure


Secondary Outcome Measures :
  1. Time to first composite renal event [ Time Frame: Baseline to approximately 51 months ]
    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)

  2. Time to first composite renal event in subgroup of patients with macroalbuminuria [ Time Frame: Baseline to approximately 51 months ]
    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

  3. Total number of heart failure events [ Time Frame: Baseline to approximately 51 months ]
    Total number (ie, including recurrent events) of the following clinical events: Cardiovascular death, Hospitalization for heart failure; Urgent heart failure visit

  4. Cardiovascular (CV) death [ Time Frame: Baseline to approximately 51 months ]
    Time to CV death

  5. All cause mortality [ Time Frame: Baseline to approximately 51 months ]
    Time to all-cause mortality



Information from the National Library of Medicine

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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.


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


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

  Show 753 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03315143     History of Changes
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: August 13, 2019
Last Verified: August 2019
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. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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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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Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
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