Loading clinical trials...
Loading clinical trials...
A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 8404018
Birmingham, Alabama, United States
Investigational Site Number 8404045
Guntersville, Alabama, United States
Investigational Site Number 8404004
Phoenix, Arizona, United States
Investigational Site Number 8404022
Phoenix, Arizona, United States
Investigational Site Number 8404007
Little Rock, Arkansas, United States
Investigational Site Number 8404023
Chula Vista, California, United States
Investigational Site Number 8404044
Gold River, California, United States
Investigational Site Number 8404011
Los Angeles, California, United States
Investigational Site Number 8404003
Norco, California, United States
Investigational Site Number 8404025
Northridge, California, United States
Start Date
August 16, 2017
Primary Completion Date
March 25, 2019
Completion Date
October 25, 2019
Last Updated
June 25, 2021
787
ACTUAL participants
Placebo
DRUG
Sotagliflozin
DRUG
Lead Sponsor
Lexicon Pharmaceuticals
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07433062