Loading clinical trials...
Loading clinical trials...
A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy
Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]). * To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. * To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. * To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 8407040
Birmingham, Alabama, United States
Investigational Site Number 8407048
Birmingham, Alabama, United States
Investigational Site Number 8407035
Little Rock, Arkansas, United States
Investigational Site Number 8407051
Anaheim, California, United States
Investigational Site Number 8407065
Canoga Park, California, United States
Investigational Site Number 8407078
Carmichael, California, United States
Investigational Site Number 8407089
Downey, California, United States
Investigational Site Number 8407011
Gold River, California, United States
Investigational Site Number 8407044
Greenbrae, California, United States
Investigational Site Number 8407006
Huntington Park, California, United States
Start Date
December 1, 2017
Primary Completion Date
August 6, 2019
Completion Date
September 6, 2019
Last Updated
May 11, 2021
954
ACTUAL participants
Sotagliflozin (SAR439954)
DRUG
Glimepiride
DRUG
Metformin
DRUG
Placebo
DRUG
Placebo
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 ConditionsNCT04943861