Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT02926937
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.
Secondary Objectives:
* To compare Sotagliflozin 400 mg versus placebo based on:
* Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
* Change from baseline in fasting plasma glucose (FPG).
* Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter per mercury (mmHg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Proportion of participants with HbA1c \<6.5%, \<7.0%.
* To compare Sotagliflozin 200 mg versus placebo based on:
* Change from baseline in HbA1c.
* Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.
* Change from baseline in body weight.
* Change from baseline in SBP for all participants.
* To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.
- Detailed Description
Up to 34 weeks, including a Screening Period consisting of a Screening Phase of up to 2 weeks and a 2-week single-blind placebo Run-in Phase, a 26-week double-blind Treatment Period, and a 4-week post-treatment Follow-up visit to collect safety information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotagliflozin 200 mg Placebo Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 Sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Placebo Placebo Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Sotagliflozin 400 mg Sotagliflozin (SAR439954) Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets, once daily (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks. Sotagliflozin 200 mg Sotagliflozin (SAR439954) Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 Sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 26 An analysis of covariance (ANCOVA) model was used for the analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) Baseline to Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) Week 26 Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) Week 26 Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) Baseline to Week 26 An ANCOVA model was used for the analysis.
Trial Locations
- Locations (70)
Investigational Site Number 4841010
🇲🇽Aguascalientes, Mexico
Investigational Site Number 4841001
🇲🇽Culiacan, Mexico
Investigational Site Number 4841005
🇲🇽Durango, Durango, Mexico
Investigational Site Number 4841002
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number 8401011
🇺🇸Los Angeles, California, United States
Investigational Site Number 8401035
🇺🇸San Dimas, California, United States
Investigational Site Number 8401024
🇺🇸Bradenton, Florida, United States
Investigational Site Number 8401007
🇺🇸Hialeah, Florida, United States
Investigational Site Number 8401051
🇺🇸Anderson, South Carolina, United States
Investigational Site Number 8401033
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 8401048
🇺🇸Akron, Ohio, United States
Investigational Site Number 8401023
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 8401049
🇺🇸Tucson, Arizona, United States
Investigational Site Number 8401058
🇺🇸Garden Grove, California, United States
Investigational Site Number 8401017
🇺🇸Huntington Park, California, United States
Investigational Site Number 8401044
🇺🇸Chicago, Illinois, United States
Investigational Site Number 4841004
🇲🇽Chihuahua, Mexico
Investigational Site Number 8401057
🇺🇸Canoga Park, California, United States
Investigational Site Number 8401014
🇺🇸Daytona Beach, Florida, United States
Investigational Site Number 8401038
🇺🇸Lake Charles, Louisiana, United States
Investigational Site Number 8401028
🇺🇸Anaheim, California, United States
Investigational Site Number 8401022
🇺🇸Montclair, California, United States
Investigational Site Number 8401039
🇺🇸Norwalk, California, United States
Investigational Site Number 8401026
🇺🇸Tucson, Arizona, United States
Investigational Site Number 8401029
🇺🇸Hawaiian Gardens, California, United States
Investigational Site Number 8401056
🇺🇸Long Beach, California, United States
Investigational Site Number 8401013
🇺🇸Long Beach, California, United States
Investigational Site Number 8401063
🇺🇸Los Angeles, California, United States
Investigational Site Number 8401025
🇺🇸Tustin, California, United States
Investigational Site Number 4841006
🇲🇽Aguascalientes, Mexico
Investigational Site Number 8401003
🇺🇸Marion, Ohio, United States
Investigational Site Number 4841003
🇲🇽Cd. México, México, Mexico
Investigational Site Number 4841009
🇲🇽Guadalajara, Mexico
Investigational Site Number 4841007
🇲🇽Mexico, Mexico
Investigational Site Number 4841008
🇲🇽Monterrey, Mexico
Investigational Site Number 8401050
🇺🇸Houston, Texas, United States
Investigational Site Number 8401008
🇺🇸Miami, Florida, United States
Investigational Site Number 8401001
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8401015
🇺🇸Van Nuys, California, United States
Investigational Site Number 8401062
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 8401031
🇺🇸Denver, Colorado, United States
Investigational Site Number 8401002
🇺🇸Greer, South Carolina, United States
Investigational Site Number 8401060
🇺🇸Northglenn, Colorado, United States
Investigational Site Number 8401040
🇺🇸Clearwater, Florida, United States
Investigational Site Number 8401046
🇺🇸Homestead, Florida, United States
Investigational Site Number 8401018
🇺🇸Miami, Florida, United States
Investigational Site Number 8401061
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 8401016
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 8401042
🇺🇸Fayetteville, North Carolina, United States
Investigational Site Number 1241006
🇨🇦Vancouver, Canada
Investigational Site Number 8401012
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8401052
🇺🇸Newton, Iowa, United States
Investigational Site Number 8401034
🇺🇸Wichita, Kansas, United States
Investigational Site Number 8401041
🇺🇸Levittown, Pennsylvania, United States
Investigational Site Number 8401020
🇺🇸Corvallis, Oregon, United States
Investigational Site Number 8401006
🇺🇸Eugene, Oregon, United States
Investigational Site Number 8401010
🇺🇸Suffolk, Virginia, United States
Investigational Site Number 8401055
🇺🇸Schertz, Texas, United States
Investigational Site Number 8401005
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 1241005
🇨🇦Toronto, Canada
Investigational Site Number 1241001
🇨🇦Toronto, Canada
Investigational Site Number 8401019
🇺🇸Houston, Texas, United States
Investigational Site Number 8401059
🇺🇸North Richland Hills, Texas, United States
Investigational Site Number 8401004
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8401037
🇺🇸Katy, Texas, United States
Investigational Site Number 8401043
🇺🇸McAllen, Texas, United States
Investigational Site Number 8401054
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8401032
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 1241002
🇨🇦Sherbrooke, Canada
Investigational Site Number 8401053
🇺🇸Orlando, Florida, United States