MedTrace Logo

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

NCT03315143 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10584

Last updated 2022-10-28

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2020-07-08
Completion
2020-07-08
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315143 on ClinicalTrials.gov