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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Type 2 Diabetes Mellitus, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT03315143

Run by

Lexicon Pharmaceuticals

People needed

10584

Starts

2017-12-19

Expected to finish

2020-07-08

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Investigational Site Number 8400014 — Surprise, Arizona, United States
• Investigational Site Number 8400071 — Little Rock, Arkansas, United States
• Investigational Site Number 8400039 — Beverly Hills, California, United States
• Investigational Site Number 8400042 — Concord, California, United States
• Investigational Site Number 8400089 — Fresno, California, United States
• Investigational Site Number 8400006 — Huntington Park, California, United States
• Investigational Site Number 8400036 — Long Beach, California, United States
• Investigational Site Number 8400073 — Los Angeles, California, United States
• Investigational Site Number 8400084 — Los Angeles, California, United States
• Investigational Site Number 8400035 — Los Gatos, California, United States
• Investigational Site Number 8400043 — Northridge, California, United States
• Investigational Site Number 8400025 — Sacramento, California, United States
• Investigational Site Number 8400018 — San Dimas, California, United States
• Investigational Site Number 8400070 — Temecula, California, United States
• Investigational Site Number 8400013 — Waterbury, Connecticut, United States
• Investigational Site Number 8400095 — Bradenton, Florida, United States
• Investigational Site Number 8400090 — Clearwater, Florida, United States
• Investigational Site Number 8400121 — Clearwater, Florida, United States
• Investigational Site Number 8400049 — Cooper City, Florida, United States
• Investigational Site Number 8400092 — Hialeah, Florida, United States
• Investigational Site Number 8400017 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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