NCT03315143

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,584 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Type 2 Diabetes Mellitus
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Sotagliflozin was administered as a tablet(s), orally once daily.
DRUG	Placebo	Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Timeline

• Start date: 2017-12-19
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2017-10-19
• Last updated: 2022-10-28
• Results posted: 2022-10-28

Locations

754 sites across 45 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, North Macedonia, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study