Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02926950
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin.
Secondary Objectives:
* To compare Sotagliflozin versus placebo for.
* 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 of mercury (mmHg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Proportion of participants with HbA1c \<6.5% and \<7.0%.
* To evaluate the safety of Sotagliflozin versus placebo.
- Detailed Description
The duration of the study period is up to 87 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2 week single blind Run-in phase, a 26 week double-blind Core Treatment Period, a 53-week double-blind Extension Period, a 4 week post treatment Follow-up period to collect safety information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotagliflozin 400 mg + Metformin Metformin Following a 2-week run-in period, sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks. Placebo + Metformin Placebo Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks. Placebo + Metformin Metformin Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks. Sotagliflozin 400 mg + Metformin Sotagliflozin (SAR439954) Following a 2-week run-in period, sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 Baseline and 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 Glucose (PPG) Following a Mixed Meal at Week 26 Baseline and Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Baseline and Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26 Baseline and 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 mmHg Baseline and Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 for All Participants Baseline and Week 12 An ANCOVA model was used for the analysis.
Percentage of Participants With HbA1c <6.5% at Week 26 Week 26 Percentage of Participants With HbA1c <7.0% at Week 26 Week 26
Trial Locations
- Locations (93)
Investigational Site Number 8402041
🇺🇸Los Angeles, California, United States
Investigational Site Number 8402006
🇺🇸Hialeah, Florida, United States
Investigational Site Number 8402044
🇺🇸Hialeah, Florida, United States
Investigational Site Number 8402018
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8402054
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8402052
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8402043
🇺🇸San Diego, California, United States
Investigational Site Number 8402036
🇺🇸Miami, Florida, United States
Investigational Site Number 8402007
🇺🇸Miami, Florida, United States
Investigational Site Number 8402061
🇺🇸Miami, Florida, United States
Investigational Site Number 8402019
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 8402013
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8402032
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 1242014
🇨🇦Barrie, Canada
Investigational Site Number 1242006
🇨🇦Pointe Claire, Canada
Investigational Site Number 3482006
🇭🇺Budapest, Hungary
Investigational Site Number 3482001
🇭🇺Esztergom, Hungary
Investigational Site Number 7032005
🇸🇰Bratislava, Slovakia
Investigational Site Number 7032003
🇸🇰Malacky, Slovakia
Investigational Site Number 7032001
🇸🇰Bratislava, Slovakia
Investigational Site Number 7032002
🇸🇰Nitra, Slovakia
Investigational Site Number 8402003
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8402017
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8402020
🇺🇸Escondido, California, United States
Investigational Site Number 8402056
🇺🇸Canoga Park, California, United States
Investigational Site Number 8402067
🇺🇸Greenbrae, California, United States
Investigational Site Number 8402028
🇺🇸Gold River, California, United States
Investigational Site Number 8402025
🇺🇸Huntington Park, California, United States
Investigational Site Number 8402011
🇺🇸Lincoln, California, United States
Investigational Site Number 8402042
🇺🇸Lemon Grove, California, United States
Investigational Site Number 8402047
🇺🇸Tarzana, California, United States
Investigational Site Number 8402031
🇺🇸San Ramon, California, United States
Investigational Site Number 8402029
🇺🇸Los Angeles, California, United States
Investigational Site Number 8402001
🇺🇸Los Angeles, California, United States
Investigational Site Number 8402066
🇺🇸Long Beach, California, United States
Investigational Site Number 8402016
🇺🇸Daytona Beach, Florida, United States
Investigational Site Number 8402035
🇺🇸Hialeah, Florida, United States
Investigational Site Number 8402045
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8402060
🇺🇸Miami Beach, Florida, United States
Investigational Site Number 8402026
🇺🇸Miami, Florida, United States
Investigational Site Number 8402064
🇺🇸Miami, Florida, United States
Investigational Site Number 8402033
🇺🇸Opa-locka, Florida, United States
Investigational Site Number 8402063
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 8402008
🇺🇸Macon, Georgia, United States
Investigational Site Number 8402038
🇺🇸Winter Haven, Florida, United States
Investigational Site Number 8402069
🇺🇸Newton, Iowa, United States
Investigational Site Number 8402022
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 8402068
🇺🇸Baton Rouge, Louisiana, United States
Investigational Site Number 8402012
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 8402021
🇺🇸Rockville, Maryland, United States
Investigational Site Number 8402005
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 8402002
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 8402015
🇺🇸Eugene, Oregon, United States
Investigational Site Number 8402030
🇺🇸Dallas, Texas, United States
Investigational Site Number 8402040
🇺🇸Houston, Texas, United States
Investigational Site Number 8402010
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 8402050
🇺🇸DeSoto, Texas, United States
Investigational Site Number 8402057
🇺🇸Houston, Texas, United States
Investigational Site Number 8402065
🇺🇸Houston, Texas, United States
Investigational Site Number 8402049
🇺🇸Magnolia, Texas, United States
Investigational Site Number 8402046
🇺🇸Odessa, Texas, United States
Investigational Site Number 8402004
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8402023
🇺🇸Schertz, Texas, United States
Investigational Site Number 8402027
🇺🇸Clinton, Utah, United States
Investigational Site Number 8402034
🇺🇸Seattle, Washington, United States
Investigational Site Number 1242007
🇨🇦Etobicoke, Canada
Investigational Site Number 1242001
🇨🇦Concord, Canada
Investigational Site Number 1242005
🇨🇦Brampton, Canada
Investigational Site Number 1242004
🇨🇦Brampton, Canada
Investigational Site Number 1242010
🇨🇦Levis, Canada
Investigational Site Number 1242012
🇨🇦Newmarket, Canada
Investigational Site Number 1242013
🇨🇦Oakville, Canada
Investigational Site Number 1242008
🇨🇦Sherbrooke, Canada
Investigational Site Number 1242015
🇨🇦Toronto, Canada
Investigational Site Number 1242002
🇨🇦Toronto, Canada
Investigational Site Number 1242011
🇨🇦Vancouver, Canada
Investigational Site Number 3482002
🇭🇺Budapest, Hungary
Investigational Site Number 1242003
🇨🇦Toronto, Canada
Investigational Site Number 3482004
🇭🇺Debrecen, Hungary
Investigational Site Number 3482003
🇭🇺Budapest, Hungary
Investigational Site Number 3482007
🇭🇺Nyiregyhaza, Hungary
Investigational Site Number 7032004
🇸🇰Sturovo, Slovakia
Investigational Site Number 7032006
🇸🇰Trencin, Slovakia
Investigational Site Number 8402009
🇺🇸Boynton Beach, Florida, United States
Investigational Site Number 8402024
🇺🇸Virginia Beach, Virginia, United States
Investigational Site Number 8402058
🇺🇸Lansdale, Pennsylvania, United States
Investigational Site Number 8402051
🇺🇸La Mirada, California, United States
Investigational Site Number 8402014
🇺🇸Long Beach, California, United States
Investigational Site Number 8402037
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8402039
🇺🇸Orlando, Florida, United States
Investigational Site Number 8402059
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 8402053
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8402062
🇺🇸Omaha, Nebraska, United States