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

NCT03315143

TerminatedPhase 3

Sponsor: Lexicon Pharmaceuticals

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

Interventions: Sotagliflozin, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
  • Birmingham, Alabama, United States
  • Sheffield, Alabama, United States
  • Mesa, Arizona, United States
  • Mesa, Arizona, United States
  • Peoria, Arizona, United States
  • Surprise, Arizona, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Concord, California, United States
  • Fresno, California, United States
  • Huntington Park, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Gatos, California, United States
  • Northridge, California, United States
  • Sacramento, California, United States
  • San Dimas, California, United States
  • Temecula, California, United States
  • Waterbury, Connecticut, United States
  • Bradenton, Florida, United States
  • Clearwater, Florida, United States
  • Clearwater, Florida, United States
  • Cooper City, Florida, United States
  • Hialeah, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • + 724 more on CT.gov