Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03285594
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).
Secondary Objectives:
* To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
* To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
* To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
- Detailed Description
Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 571
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Insulin glargine (HOE901) Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Placebo Oral Antidiabetes Drugs (OADs) Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 200 mg Oral Antidiabetes Drugs (OADs) Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 200 mg Insulin glargine (HOE901) Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 400 mg Insulin glargine (HOE901) Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Placebo Placebo Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 200 mg Placebo Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 400 mg Oral Antidiabetes Drugs (OADs) Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 200 mg Sotagliflozin Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study. Sotagliflozin 400 mg Sotagliflozin Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 Baseline and Week 18 An analysis of covariance (ANCOVA) model was used for the analysis.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks An AE is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Change From Baseline in HbA1c at Week 52 Baseline and Week 52 An ANCOVA model was used for the analysis.
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12 Baseline and Week 12 An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.
Change From Baseline in SBP at Week 12 for All Participants Baseline to Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 52 Baseline and Week 52 An ANCOVA model was used for the analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 Baseline and Week 18 FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 18 Baseline and Week 18 An ANCOVA model was used for the analysis.
Trial Locations
- Locations (106)
Investigational Site Number 8406003
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 8406052
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8406043
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 8406008
🇺🇸DeLand, Florida, United States
Investigational Site Number 8406029
🇺🇸North Miami Beach, Florida, United States
Investigational Site Number 8406044
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8406022
🇺🇸Saint Petersburg, Florida, United States
Investigational Site Number 8406024
🇺🇸Rockville, Maryland, United States
Investigational Site Number 8406010
🇺🇸Papillion, Nebraska, United States
Investigational Site Number 1246003
🇨🇦Brampton, Canada
Investigational Site Number 3486008
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 7036007
🇸🇰Levice, Slovakia
Investigational Site Number 7036006
🇸🇰Nitra, Slovakia
Investigational Site Number 1006009
🇧🇬Gabrovo, Bulgaria
Investigational Site Number 8406020
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8406040
🇺🇸Los Angeles, California, United States
Investigational Site Number 8406001
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 8406002
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 8406023
🇺🇸Columbus, Ohio, United States
Investigational Site Number 8406047
🇺🇸Dallas, Texas, United States
Investigational Site Number 8406016
🇺🇸Detroit, Michigan, United States
Investigational Site Number 8406034
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 8406038
🇺🇸Greenville, North Carolina, United States
Investigational Site Number 8406054
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8406028
🇺🇸Mesa, Arizona, United States
Investigational Site Number 8406033
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 8406048
🇺🇸Houston, Texas, United States
Investigational Site Number 8406050
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8406014
🇺🇸West Jordan, Utah, United States
Investigational Site Number 8406027
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8406005
🇺🇸Dublin, Ohio, United States
Investigational Site Number 8406017
🇺🇸Dallas, Texas, United States
Investigational Site Number 8406035
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 8266001
🇬🇧Leicester, United Kingdom
Investigational Site Number 8406013
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8406006
🇺🇸Huntington Park, California, United States
Investigational Site Number 8406053
🇺🇸Lincoln, California, United States
Investigational Site Number 8406030
🇺🇸Maitland, Florida, United States
Investigational Site Number 8406042
🇺🇸Evansville, Indiana, United States
Investigational Site Number 8406018
🇺🇸New York, New York, United States
Investigational Site Number 8406011
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 8406026
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 8406036
🇺🇸Hickory, North Carolina, United States
Investigational Site Number 8406015
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 8406031
🇺🇸Beachwood, Ohio, United States
Investigational Site Number 8406004
🇺🇸Mentor, Ohio, United States
Investigational Site Number 8406009
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 8406032
🇺🇸Moncks Corner, South Carolina, United States
Investigational Site Number 8406045
🇺🇸Seymour, Tennessee, United States
Investigational Site Number 8406021
🇺🇸Shavano Park, Texas, United States
Investigational Site Number 8406039
🇺🇸McAllen, Texas, United States
Investigational Site Number 8406037
🇺🇸Houston, Texas, United States
Investigational Site Number 1006004
🇧🇬Ruse, Bulgaria
Investigational Site Number 1006003
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 1006001
🇧🇬Ruse, Bulgaria
Investigational Site Number 1006006
🇧🇬Smolyan, Bulgaria
Investigational Site Number 1006002
🇧🇬Sofia, Bulgaria
Investigational Site Number 1006010
🇧🇬Sofia, Bulgaria
Investigational Site Number 1006005
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 1006007
🇧🇬Varna, Bulgaria
Investigational Site Number 1246005
🇨🇦Burlington, Canada
Investigational Site Number 2036003
🇨🇿Holesov, Czechia
Investigational Site Number 1246004
🇨🇦Etobicoke, Canada
Investigational Site Number 7036001
🇸🇰Bratislava, Slovakia
Investigational Site Number 1246001
🇨🇦Vancouver, Canada
Investigational Site Number 2036002
🇨🇿Krnov, Czechia
Investigational Site Number 2036001
🇨🇿Olomouc, Czechia
Investigational Site Number 2036005
🇨🇿Ostrava, Czechia
Investigational Site Number 1246002
🇨🇦Toronto, Canada
Investigational Site Number 2506003
🇫🇷Corbeil-Essonnes, France
Investigational Site Number 2036006
🇨🇿Praha 10 - Uhrineves, Czechia
Investigational Site Number 2036007
🇨🇿Praha 4, Czechia
Investigational Site Number 2506008
🇫🇷Besançon Cedex, France
Investigational Site Number 2036008
🇨🇿Praha 4, Czechia
Investigational Site Number 2506005
🇫🇷Dijon, France
Investigational Site Number 2506004
🇫🇷Nantes, France
Investigational Site Number 2506012
🇫🇷Mulhouse, France
Investigational Site Number 2506007
🇫🇷Narbonne, France
Investigational Site Number 2506006
🇫🇷Paris, France
Investigational Site Number 3486002
🇭🇺Budapest, Hungary
Investigational Site Number 2506010
🇫🇷Pierre-Benite, France
Investigational Site Number 2506009
🇫🇷Poitiers, France
Investigational Site Number 2506011
🇫🇷Saint-Mande, France
Investigational Site Number 2506002
🇫🇷Vénissieux, France
Investigational Site Number 3486007
🇭🇺Budapest, Hungary
Investigational Site Number 3486009
🇭🇺Kecskemet, Hungary
Investigational Site Number 3486006
🇭🇺Hatvan, Hungary
Investigational Site Number 3486003
🇭🇺Komarom, Hungary
Investigational Site Number 3486005
🇭🇺Nyíregyháza, Hungary
Investigational Site Number 3486001
🇭🇺Pécs, Hungary
Investigational Site Number 7036010
🇸🇰Kosice, Slovakia
Investigational Site Number 7036004
🇸🇰Bardejov, Slovakia
Investigational Site Number 7036003
🇸🇰Kosice, Slovakia
Investigational Site Number 7036008
🇸🇰Bratislava, Slovakia
Investigational Site Number 8266004
🇬🇧London, United Kingdom
Investigational Site Number 7036009
🇸🇰Levice, Slovakia
Investigational Site Number 7036011
🇸🇰Lucenec, Slovakia
Investigational Site Number 7036005
🇸🇰Sabinov, Slovakia
Investigational Site Number 8266002
🇬🇧Darlington, United Kingdom
Investigational Site Number 8266006
🇬🇧Doncaster, United Kingdom
Investigational Site Number 8266008
🇬🇧Dundee, United Kingdom
Investigational Site Number 8266003
🇬🇧Salford, United Kingdom
Investigational Site Number 8406025
🇺🇸Tampa, Florida, United States
Investigational Site Number 8406046
🇺🇸Chapel Hill, North Carolina, United States
Investigational Site Number 8406019
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 8406051
🇺🇸New Orleans, Louisiana, United States