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

Phase 3TerminatedNCT03315143

Lexicon Pharmaceuticals10,584 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

10,584

Conditions

Heart Failure Type 2 Diabetes Mellitus Chronic Kidney Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (754)

Investigational Site Number 8400017

Birmingham, Alabama, United States

Investigational Site Number 8400096

Sheffield, Alabama, United States

Investigational Site Number 8400004

Mesa, Arizona, United States

Investigational Site Number 8400059

Mesa, Arizona, United States

Investigational Site Number 8400021

Peoria, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 30 months

Secondary Outcomes

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months

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.

Time frame: Up to 30 months