Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03351478
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
The purpose of the study is 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 on a DPP4(i) with or without metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 770
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin 25 mg Empagliflozin Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks. Sotagliflozin 400 mg Placebo Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks. Empagliflozin 25 mg Placebo Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks. Placebo Placebo Following a 2-week run-in period, placebo was given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks. Sotagliflozin 400 mg Sotagliflozin Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26 Baseline, Week 26 An analysis of covariance (ANCOVA) model was used for the analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg Baseline, Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26 Baseline, Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Baseline, Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26 Baseline, Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Sitting SBP at Week 12 for All Participants Baseline, 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 (160)
Investigational Site Number 8408010
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 8408038
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 1008005
🇧🇬Ruse, Bulgaria
Investigational Site Number 1008002
🇧🇬Smolyan, Bulgaria
Investigational Site Number 8408056
🇺🇸Dallas, Texas, United States
Investigational Site Number 8408052
🇺🇸Dallas, Texas, United States
Investigational Site Number 8408009
🇺🇸Miami, Florida, United States
Investigational Site Number 8408001
🇺🇸Houston, Texas, United States
Investigational Site Number 8408032
🇺🇸Houston, Texas, United States
Investigational Site Number 8408016
🇺🇸Houston, Texas, United States
Investigational Site Number 8408017
🇺🇸Houston, Texas, United States
Investigational Site Number 8408035
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8408067
🇺🇸Van Nuys, California, United States
Investigational Site Number 8408028
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 8408047
🇺🇸Hawaiian Gardens, California, United States
Investigational Site Number 8408031
🇺🇸Spring Valley, California, United States
Investigational Site Number 8408069
🇺🇸Northglenn, Colorado, United States
Investigational Site Number 8408049
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8408005
🇺🇸Orlando, Florida, United States
Investigational Site Number 8408019
🇺🇸Palmetto Bay, Florida, United States
Investigational Site Number 8408040
🇺🇸Orlando, Florida, United States
Investigational Site Number 8408064
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 8408061
🇺🇸Columbus, Georgia, United States
Investigational Site Number 8408074
🇺🇸Macon, Georgia, United States
Investigational Site Number 8408059
🇺🇸Statesboro, Georgia, United States
Investigational Site Number 8408079
🇺🇸Savannah, Georgia, United States
Investigational Site Number 8408002
🇺🇸Rockville, Maryland, United States
Investigational Site Number 8408051
🇺🇸Blackfoot, Idaho, United States
Investigational Site Number 8408033
🇺🇸Elgin, Illinois, United States
Investigational Site Number 8408003
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8408044
🇺🇸Fall River, Massachusetts, United States
Investigational Site Number 8408027
🇺🇸West Seneca, New York, United States
Investigational Site Number 8408053
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8408037
🇺🇸Fayetteville, North Carolina, United States
Investigational Site Number 8408012
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8408013
🇺🇸Salisbury, North Carolina, United States
Investigational Site Number 8408045
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 8408068
🇺🇸Warwick, Rhode Island, United States
Investigational Site Number 8408060
🇺🇸Fort Mill, South Carolina, United States
Investigational Site Number 8408018
🇺🇸Jefferson City, Tennessee, United States
Investigational Site Number 8408082
🇺🇸Dallas, Texas, United States
Investigational Site Number 8408072
🇺🇸Brownsville, Texas, United States
Investigational Site Number 8408036
🇺🇸Houston, Texas, United States
Investigational Site Number 8408029
🇺🇸Katy, Texas, United States
Investigational Site Number 8408022
🇺🇸Houston, Texas, United States
Investigational Site Number 8408039
🇺🇸Mesquite, Texas, United States
Investigational Site Number 8408054
🇺🇸McAllen, Texas, United States
Investigational Site Number 8408042
🇺🇸Plano, Texas, United States
Investigational Site Number 8408041
🇺🇸Schertz, Texas, United States
Investigational Site Number 8408006
🇺🇸Burke, Virginia, United States
Investigational Site Number 8408026
🇺🇸Holladay, Utah, United States
Investigational Site Number 8408007
🇺🇸Bountiful, Utah, United States
Investigational Site Number 8408004
🇺🇸Manassas, Virginia, United States
Investigational Site Number 1008001
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 1008007
🇧🇬Ruse, Bulgaria
Investigational Site Number 1008008
🇧🇬Sofia, Bulgaria
Investigational Site Number 1008003
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 1008012
🇧🇬Sofia, Bulgaria
Investigational Site Number 1008010
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 1008004
🇧🇬Varna, Bulgaria
Investigational Site Number 1248007
🇨🇦Burlington, Canada
Investigational Site Number 1248003
🇨🇦Newmarket, Canada
Investigational Site Number 1248010
🇨🇦Quebec, Canada
Investigational Site Number 1248001
🇨🇦Brampton, Canada
Investigational Site Number 1248009
🇨🇦Sherbrooke, Canada
Investigational Site Number 1248002
🇨🇦Thornhill, Canada
Investigational Site Number 1248011
🇨🇦Toronto, Canada
Investigational Site Number 1248008
🇨🇦Victoriaville, Canada
Investigational Site Number 2038003
🇨🇿Havirov, Czechia
Investigational Site Number 2038011
🇨🇿Ostrava, Czechia
Investigational Site Number 2038006
🇨🇿Pardubice, Czechia
Investigational Site Number 2038005
🇨🇿Prague, Czechia
Investigational Site Number 2038010
🇨🇿Plzen, Czechia
Investigational Site Number 2038002
🇨🇿Praha 4, Czechia
Investigational Site Number 2038001
🇨🇿Praha 10 - Uhrineves, Czechia
Investigational Site Number 2038013
🇨🇿Praha 2, Czechia
Investigational Site Number 2038009
🇨🇿Praha 1, Czechia
Investigational Site Number 2508005
🇫🇷Corbeil-Essonnes, France
Investigational Site Number 2038008
🇨🇿Praha 9, Czechia
Investigational Site Number 2508006
🇫🇷La Roche Sur Yon, France
Investigational Site Number 2508007
🇫🇷La Tronche, France
Investigational Site Number 2508003
🇫🇷Mulhouse, France
Investigational Site Number 2508002
🇫🇷Nantes Cedex 1, France
Investigational Site Number 2508001
🇫🇷Paris, France
Investigational Site Number 3808010
🇮🇹Catania, Italy
Investigational Site Number 2508004
🇫🇷Saint-Mandé, France
Investigational Site Number 3808003
🇮🇹Catania, Italy
Investigational Site Number 3808009
🇮🇹Pavia, Italy
Investigational Site Number 3808005
🇮🇹Milano, Italy
Investigational Site Number 3808004
🇮🇹Milano, Italy
Investigational Site Number 3808001
🇮🇹Roma, Italy
Investigational Site Number 3808008
🇮🇹Roma, Italy
Investigational Site Number 7248006
🇪🇸Barcelona, Spain
Investigational Site Number 7248002
🇪🇸Córdoba, Spain
Investigational Site Number 8408011
🇺🇸San Antonio, Texas, United States
Investigational Site Number 3808002
🇮🇹Chieti, Italy
Investigational Site Number 1248004
🇨🇦Toronto, Canada
Investigational Site Number 1248005
🇨🇦Vancouver, Canada
Investigational Site Number 1008006
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 2038007
🇨🇿Brandys, Czechia
Investigational Site Number 4848007
🇲🇽Durango, Durango, Mexico
Investigational Site Number 7248005
🇪🇸Malaga Malaga, Spain
Investigational Site Number 7248003
🇪🇸Valencia Valencia, Spain
Investigational Site Number 1008011
🇧🇬Gabrovo, Bulgaria
Investigational Site Number 2038004
🇨🇿Krnov, Czechia
Investigational Site Number 4288008
🇱🇻Limbazi, Latvia
Investigational Site Number 3808011
🇮🇹San Giovanni Rotondo, Italy
Investigational Site Number 3808007
🇮🇹Roma, Italy
Investigational Site Number 4288004
🇱🇻Kuldiga, Latvia
Investigational Site Number 4288003
🇱🇻Ogre, Latvia
Investigational Site Number 4288007
🇱🇻Riga, Latvia
Investigational Site Number 4288001
🇱🇻Riga, Latvia
Investigational Site Number 3808006
🇮🇹Siena, Italy
Investigational Site Number 4288005
🇱🇻Talsi, Latvia
Investigational Site Number 4848003
🇲🇽Cuernavaca, Mexico
Investigational Site Number 4848001
🇲🇽Monterrey, Mexico
Investigational Site Number 4848012
🇲🇽Monterrey, Mexico
Investigational Site Number 6438008
🇷🇺Chelyabinsk, Russian Federation
Investigational Site Number 4288002
🇱🇻Riga, Latvia
Investigational Site Number 4288006
🇱🇻Sigulda, Latvia
Investigational Site Number 4848002
🇲🇽Chihuahua, Mexico
Investigational Site Number 6438003
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6438014
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 7038003
🇸🇰Vrutky, Slovakia
Investigational Site Number 4848011
🇲🇽Mexico City, Mexico
Investigational Site Number 4848005
🇲🇽Monterrey, Mexico
Investigational Site Number 6438006
🇷🇺Dzerzhinsky, Russian Federation
Investigational Site Number 6438009
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 6438010
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 6438013
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6438002
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6438005
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6438001
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6438012
🇷🇺Saratov, Russian Federation
Investigational Site Number 6438015
🇷🇺Volgograd, Russian Federation
Investigational Site Number 6438007
🇷🇺Vsevolozhsk, Russian Federation
Investigational Site Number 6438011
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 7038005
🇸🇰Bardejov, Slovakia
Investigational Site Number 7038001
🇸🇰Kosice, Slovakia
Investigational Site Number 7038009
🇸🇰Bratislava, Slovakia
Investigational Site Number 8268002
🇬🇧Huntingdon, United Kingdom
Investigational Site Number 8268003
🇬🇧Southampton, United Kingdom
Investigational Site Number 7248001
🇪🇸Sevilla, Spain
Investigational Site Number 7038006
🇸🇰Lucenec, Slovakia
Investigational Site Number 7038008
🇸🇰Nove Zamky, Slovakia
Investigational Site Number 7038004
🇸🇰Povazska Bystrica, Slovakia
Investigational Site Number 7038002
🇸🇰Roznava, Slovakia
Investigational Site Number 7038007
🇸🇰Sabinov, Slovakia
Investigational Site Number 7248010
🇪🇸Santa Coloma De Gramenet, Spain
Investigational Site Number 7248009
🇪🇸Santiago De Compostela, Spain
Investigational Site Number 8268008
🇬🇧Darlington, United Kingdom
Investigational Site Number 8268004
🇬🇧Dundee, United Kingdom
Investigational Site Number 8268006
🇬🇧Exeter, United Kingdom
Investigational Site Number 8268001
🇬🇧Hull, United Kingdom
Investigational Site Number 8268007
🇬🇧Sheffield, United Kingdom
Investigational Site Number 8268005
🇬🇧Wolverhampton, United Kingdom
Investigational Site Number 7248004
🇪🇸Sevilla, Spain
Investigational Site Number 7248007
🇪🇸Zaragoza, Spain
Investigational Site Number 7248008
🇪🇸Sevilla, Spain
Investigational Site Number 8408008
🇺🇸Flint, Michigan, United States