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Trial record 2 of 256959 for:    ALL

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

This study is not yet open for participant recruitment.
Verified October 2017 by Sanofi
Sponsor:
ClinicalTrials.gov Identifier:
NCT03315143
First Posted: October 19, 2017
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus Chronic Kidney Diseases Drug: Sotagliflozin (SAR439954) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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

  • 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:
  • 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)

  • 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

  • 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

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

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


Estimated Enrollment: 10500
Anticipated Study Start Date: November 30, 2017
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

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 Submitted: October 16, 2017
First Posted: October 19, 2017
Last Update Posted: October 19, 2017
Last Verified: October 2017
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/
URL: http://

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency