Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03066830
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.
Secondary Objectives:
* To compare Sotagliflozin 400 mg versus placebo based on:
* 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 (mm Hg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Percentage of participants with HbA1c \<6.5% and \<7.0%.
* To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.
- Detailed Description
The duration per participants is up to 85 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, and a 2-week post treatment Follow-up period to collect safety information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. Placebo Sulfonylurea Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. Sotagliflozin 400 mg Sotagliflozin (SAR439954) Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks. Placebo Metformin Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 Baseline to Week 26 Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Body Weight at Week 26 Baseline to Week 26 Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg Baseline to Week 12 Missing data are imputed using the washout imputation method under the missing, not at random framework. An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 for All Participants Baseline to Week 12 Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.
Percentage of Participants With HbA1c <6.5% at Week 26 Week 26 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Baseline to Week 26 Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Percentage of Participants With HbA1c <7.0% at Week 26 Week 26
Trial Locations
- Locations (76)
Investigational Site Number 2333003
🇪🇪Parnu, Estonia
Investigational Site Number 1003002
🇧🇬Ruse, Bulgaria
Investigational Site Number 8043002
🇺🇦Kyiv, Ukraine
Investigational Site Number 1003003
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 3483005
🇭🇺Kecskemet, Hungary
Investigational Site Number 6163006
🇵🇱Gdynia, Poland
Investigational Site Number 7033001
🇸🇰Bratislava, Slovakia
Investigational Site Number 7033004
🇸🇰Malacky, Slovakia
Investigational Site Number 7033003
🇸🇰Sturovo, Slovakia
Investigational Site Number 3483006
🇭🇺Budapest, Hungary
Investigational Site Number 3483003
🇭🇺Pécs, Hungary
Investigational Site Number 6163005
🇵🇱Gdansk, Poland
Investigational Site Number 3483001
🇭🇺Balatonfüred, Hungary
Investigational Site Number 3483009
🇭🇺Hatvan, Hungary
Investigational Site Number 6163004
🇵🇱Wroclaw, Poland
Investigational Site Number 6423002
🇷🇴Iasi, Romania
Investigational Site Number 3483008
🇭🇺Budapest, Hungary
Investigational Site Number 1003004
🇧🇬Sofia, Bulgaria
Investigational Site Number 3483012
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 8043001
🇺🇦Kyiv, Ukraine
Investigational Site Number 3483010
🇭🇺Budapest, Hungary
Investigational Site Number 3483004
🇭🇺Budapest, Hungary
Investigational Site Number 6163001
🇵🇱Warszawa, Poland
Investigational Site Number 7033006
🇸🇰Bratislava, Slovakia
Investigational Site Number 7033002
🇸🇰Bratislava, Slovakia
Investigational Site Number 8043003
🇺🇦Kyiv, Ukraine
Investigational Site Number 8403021
🇺🇸Henderson, Nevada, United States
Investigational Site Number 8403030
🇺🇸Kingsport, Tennessee, United States
Investigational Site Number 8403003
🇺🇸Litchfield Park, Arizona, United States
Investigational Site Number 8403006
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number 8403028
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8403025
🇺🇸Richfield, Minnesota, United States
Investigational Site Number 8403005
🇺🇸Burke, Virginia, United States
Investigational Site Number 8403018
🇺🇸Peoria, Arizona, United States
Investigational Site Number 8403012
🇺🇸Huntington Park, California, United States
Investigational Site Number 8403026
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8403015
🇺🇸Shelby, North Carolina, United States
Investigational Site Number 8403011
🇺🇸Flint, Michigan, United States
Investigational Site Number 3483007
🇭🇺Budapest, Hungary
Investigational Site Number 3483011
🇭🇺Gyula, Hungary
Investigational Site Number 8263007
🇬🇧Glasgow, United Kingdom
Investigational Site Number 4103001
🇰🇷Goyang-Si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 8403008
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 4103011
🇰🇷Guri-Si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 8403007
🇺🇸Nampa, Idaho, United States
Investigational Site Number 4103010
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4103005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4103009
🇰🇷Wonju-Si, Gangwon-Do, Korea, Republic of
Investigational Site Number 4103006
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 8403033
🇺🇸Hatboro, Pennsylvania, United States
Investigational Site Number 8403013
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 8403002
🇺🇸Dallas, Texas, United States
Investigational Site Number 8263011
🇬🇧Manchester, United Kingdom
Investigational Site Number 8263012
🇬🇧Birmingham, United Kingdom
Investigational Site Number 8263008
🇬🇧Hexham, United Kingdom
Investigational Site Number 8263014
🇬🇧Liverpool, United Kingdom
Investigational Site Number 8263009
🇬🇧Cardiff, United Kingdom
Investigational Site Number 8263003
🇬🇧Inverness, United Kingdom
Investigational Site Number 8263010
🇬🇧Reading, United Kingdom
Investigational Site Number 4103007
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4103003
🇰🇷Seongnam-Si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 6163003
🇵🇱Katowice, Poland
Investigational Site Number 6163002
🇵🇱Poznan, Poland
Investigational Site Number 6423004
🇷🇴Bucuresti, Romania
Investigational Site Number 7033007
🇸🇰Trencin, Slovakia
Investigational Site Number 8403022
🇺🇸Houston, Texas, United States
Investigational Site Number 8403009
🇺🇸Greenbrae, California, United States
Investigational Site Number 8403019
🇺🇸Los Angeles, California, United States
Investigational Site Number 8403034
🇺🇸Montclair, California, United States
Investigational Site Number 8403014
🇺🇸Tustin, California, United States
Investigational Site Number 8403016
🇺🇸Spring Valley, California, United States
Investigational Site Number 8403001
🇺🇸Northglenn, Colorado, United States
Investigational Site Number 8403029
🇺🇸Bradenton, Florida, United States
Investigational Site Number 8403004
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 8403020
🇺🇸North Miami Beach, Florida, United States
Investigational Site Number 8403032
🇺🇸Orlando, Florida, United States