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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

Tracking Information
First Submitted Date  ICMJE October 16, 2017
First Posted Date  ICMJE October 19, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE November 28, 2017
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03315143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Chronic Kidney Diseases
Intervention  ICMJE
  • Drug: Sotagliflozin (SAR439954)

    Pharmaceutical form: tablet

    Route of administration: oral

  • Drug: Placebo

    Pharmaceutical form: tablet

    Route of administration: oral

Study Arms  ICMJE
  • Experimental: Sotagliflozin
    Sotagliflozin dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
    Intervention: Drug: Sotagliflozin (SAR439954)
  • Placebo Comparator: Placebo
    Placebo dose 1 (1 tablet), once daily with possible uptitration in the first 6 months to dose 2 (2 tablets)
    Intervention: Drug: Placebo
Publications * Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
10500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   Denmark,   Estonia,   France,   Georgia,   Germany,   Greece,   Guatemala,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   North Macedonia,   Norway,   Peru,   Poland,   Portugal,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Former Yugoslavia,   Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT03315143
Other Study ID Numbers  ICMJE EFC14875
2017-002644-32
U1111-1187-8703 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP