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NCT03315143 Clinical Trial

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

Heart Failure Clinical Trial

— SCORED  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03315143
Other study ID # EFC14875
Secondary ID 2017-002644-32U1
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 19, 2017
Est. completion date July 8, 2020

Study information
Verified date September 2022
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study was 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 participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

Recruitment information / eligibility
Status Terminated
Enrollment 10584
Est. completion date July 8, 2020
Est. primary completion date July 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : - Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) =7%. - Estimated glomerular filtration rate (eGFR) =25 and =60 milliliter/minute (mL/min)/1.73 square meter (m^2). - 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 participant's potential participation in a clinical trial.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sotagliflozin
Sotagliflozin was administered as a tablet(s), orally once daily.
• Placebo
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Locations
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Argentina Investigational Site Number 0320016 Buenos Aires
Argentina Investigational Site Number 0320029 Buenos Aires
Argentina Investigational Site Number 0320002 Caba
Argentina Investigational Site Number 0320004 Caba
Argentina Investigational Site Number 0320017 Caba
Argentina Investigational Site Number 0320018 Caba
Argentina Investigational Site Number 0320019 Caba
Argentina Investigational Site Number 0320025 Caba
Argentina Investigational Site Number 0320015 Capital Federal
Argentina Investigational Site Number 0320027 Capital Federal
Argentina Investigational Site Number 0320014 Ciudad Autonoma De Bs.As
Argentina Investigational Site Number 0320023 Ciudad Autonoma De Buenos Aire
Argentina Investigational Site Number 0320009 Ciudadela
Argentina Investigational Site Number 0320001 Cordoba
Argentina Investigational Site Number 0320008 Coronel Suarez
Argentina Investigational Site Number 0320011 Corrientes
Argentina Investigational Site Number 0320006 La Plata
Argentina Investigational Site Number 0320028 La Plata
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Argentina Investigational Site Number 0320024 Mar Del Plata
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Sponsors (2)
Lead Sponsor Collaborator
Lexicon Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  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,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Total Number of Occurrences of HHF and Urgent HF Visits Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Number of Deaths From Cardiovascular Causes Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Number of Occurrences After Randomization of the Composite of Sustained =50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for =30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for =30 Days) Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Number of Deaths From Any Cause Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
Secondary Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 30 months
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