Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- Registration Number
- NCT03386344
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.
- Detailed Description
Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period.
Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 376
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 to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, 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 106 weeks. Sotagliflozin 400 mg Sotagliflozin Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, 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 104 weeks. 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, once daily, before the first meal of the day, 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 104 weeks. Sotagliflozin 200 mg Sotagliflozin Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, 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 104 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 Baseline to Week 26 An analysis of covariance (ANCOVA) model is used for analysis.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26 Week 26 Change From Baseline in Body Weight at Week 26 Baseline to Week 26 An ANCOVA model is used for analysis.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 Baseline to Week 26 An ANCOVA model is used for analysis.
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 Baseline to Week 26 An ANCOVA model is used for analysis.
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 Baseline to Week 26 An ANCOVA model is used for analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Baseline to Week 26 An ANCOVA model is used for analysis.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 Baseline to Week 12 An ANCOVA model is used for analysis.
Percentage of Participants With Adverse Events (AEs) up to 106 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Trial Locations
- Locations (53)
Investigational Site Number 1249003
🇨🇦Brampton, Canada
Investigational Site Number 1249005
🇨🇦Pointe-Claire, Canada
Investigational Site Number 1249007
🇨🇦Vancouver, Canada
Investigational Site Number 4109006
🇰🇷Daejeon, Korea, Republic of
Investigational Site Number 1249002
🇨🇦Victoriaville, Canada
Investigational Site Number 8409011
🇺🇸Evansville, Indiana, United States
Investigational Site Number 6439007
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 1589003
🇨🇳Taipei, Taiwan
Investigational Site Number 8409004
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 8409003
🇺🇸Dallas, Texas, United States
Investigational Site Number 8409014
🇺🇸Wichita, Kansas, United States
Investigational Site Number 8409009
🇺🇸Escondido, California, United States
Investigational Site Number 8409010
🇺🇸Greenbrae, California, United States
Investigational Site Number 8409005
🇺🇸Walnut Creek, California, United States
Investigational Site Number 8409012
🇺🇸Columbus, Georgia, United States
Investigational Site Number 8409015
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 8409002
🇺🇸Chapel Hill, North Carolina, United States
Investigational Site Number 8409001
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 8409008
🇺🇸Dayton, Ohio, United States
Investigational Site Number 0369003
🇦🇺Fremantle, Australia
Investigational Site Number 8409007
🇺🇸Katy, Texas, United States
Investigational Site Number 8409013
🇺🇸Austin, Texas, United States
Investigational Site Number 0369002
🇦🇺Merewether, Australia
Investigational Site Number 0369004
🇦🇺Parkville, Australia
Investigational Site Number 1249006
🇨🇦Thornhill, Canada
Investigational Site Number 1249008
🇨🇦Etobicoke, Canada
Investigational Site Number 1249004
🇨🇦Thornhill, Canada
Investigational Site Number 4109005
🇰🇷Guri-Si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 4109004
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4849006
🇲🇽Aguascalientes, Aguascalientes, Mexico
Investigational Site Number 4109003
🇰🇷Gyeonggi-Do, Korea, Republic of
Investigational Site Number 4849001
🇲🇽Aguascalientes, Mexico
Investigational Site Number 4849002
🇲🇽Guadalajara Jalisco, Mexico
Investigational Site Number 4849003
🇲🇽Cuernavaca, Mexico
Investigational Site Number 4849004
🇲🇽Monterrey, Mexico
Investigational Site Number 4849005
🇲🇽Xalapa, Mexico
Investigational Site Number 5549004
🇳🇿Auckland, New Zealand
Investigational Site Number 5549001
🇳🇿Rotorua, New Zealand
Investigational Site Number 5549003
🇳🇿Christchurch, New Zealand
Investigational Site Number 5549002
🇳🇿Wellington, New Zealand
Investigational Site Number 6439005
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 6439002
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6439003
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6439001
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 6439006
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 1589005
🇨🇳Changhua, Taiwan
Investigational Site Number 1589008
🇨🇳New Taipei City, Taiwan
Investigational Site Number 1589006
🇨🇳Taichung, Taiwan
Investigational Site Number 1589007
🇨🇳Taichung, Taiwan
Investigational Site Number 1589001
🇨🇳Tainan, Taiwan
Investigational Site Number 1589002
🇨🇳Tainan, Taiwan
Investigational Site Number 1589004
🇨🇳Taipei, Taiwan
Investigational Site Number 4109001
🇰🇷Seoul, Korea, Republic of