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Clinical Trial Details

Trial ID: L6702
Source ID: NCT03351478
Associated Drug: Sotagliflozin
Title: 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
Acronym: SOTA-EMPA
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03351478/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin|DRUG: Empagliflozin|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26, An analysis of covariance (ANCOVA) model was used for the analysis., Baseline, Week 26 | Secondary: Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg, An ANCOVA model was used for the analysis., Baseline, Week 12|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26, An ANCOVA model was used for the analysis., Baseline, Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, An ANCOVA model was used for the analysis., Baseline, Week 26|Change From Baseline in Body Weight at Week 26, An ANCOVA model was used for the analysis., Baseline, Week 26|Change From Baseline in Sitting SBP at Week 12 for All Participants, An ANCOVA model was used for the analysis., Baseline, Week 12|Percentage of Participants With HbA1c <6.5% at Week 26, Week 26|Percentage of Participants With HbA1c <7.0% at Week 26, Week 26
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 770
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-11-27
Completion Date: 2019-05-16
Results First Posted: 2021-05-11
Last Update Posted: 2021-05-11
Locations: Investigational Site Number 8408035, Birmingham, Alabama, 35205, United States|Investigational Site Number 8408028, Sheffield, Alabama, 35660, United States|Investigational Site Number 8408047, Hawaiian Gardens, California, 90716, United States|Investigational Site Number 8408031, Spring Valley, California, 91978, United States|Investigational Site Number 8408067, Van Nuys, California, 91405, United States|Investigational Site Number 8408069, Northglenn, Colorado, 80234, United States|Investigational Site Number 8408009, Miami, Florida, 33183-4825, United States|Investigational Site Number 8408049, Ocoee, Florida, 34761, United States|Investigational Site Number 8408005, Orlando, Florida, 32810, United States|Investigational Site Number 8408040, Orlando, Florida, 32825, United States|Investigational Site Number 8408019, Palmetto Bay, Florida, 33157-5503, United States|Investigational Site Number 8408064, Port Charlotte, Florida, 33952, United States|Investigational Site Number 8408061, Columbus, Georgia, 31904, United States|Investigational Site Number 8408074, Macon, Georgia, 31210, United States|Investigational Site Number 8408079, Savannah, Georgia, 31406, United States|Investigational Site Number 8408059, Statesboro, Georgia, 30461-0845, United States|Investigational Site Number 8408051, Blackfoot, Idaho, 83221, United States|Investigational Site Number 8408033, Elgin, Illinois, 60124, United States|Investigational Site Number 8408003, New Orleans, Louisiana, 70124, United States|Investigational Site Number 8408002, Rockville, Maryland, 20852, United States|Investigational Site Number 8408044, Fall River, Massachusetts, 02721-3005, United States|Investigational Site Number 8408008, Flint, Michigan, 48532, United States|Investigational Site Number 8408027, West Seneca, New York, 14224, United States|Investigational Site Number 8408037, Fayetteville, North Carolina, 28314, United States|Investigational Site Number 8408053, Greensboro, North Carolina, 27408-7042, United States|Investigational Site Number 8408012, Greensboro, North Carolina, 27408, United States|Investigational Site Number 8408013, Salisbury, North Carolina, 28144-2742, United States|Investigational Site Number 8408045, Oklahoma City, Oklahoma, 73104-3252, United States|Investigational Site Number 8408068, Warwick, Rhode Island, 02888-3360, United States|Investigational Site Number 8408060, Fort Mill, South Carolina, 29707-4514, United States|Investigational Site Number 8408018, Jefferson City, Tennessee, 37760, United States|Investigational Site Number 8408010, Knoxville, Tennessee, 37912-4707, United States|Investigational Site Number 8408038, Knoxville, Tennessee, 37938, United States|Investigational Site Number 8408072, Brownsville, Texas, 78520-7512, United States|Investigational Site Number 8408056, Dallas, Texas, 75208, United States|Investigational Site Number 8408082, Dallas, Texas, 75230, United States|Investigational Site Number 8408052, Dallas, Texas, 75231, United States|Investigational Site Number 8408001, Houston, Texas, 77004, United States|Investigational Site Number 8408032, Houston, Texas, 77004, United States|Investigational Site Number 8408016, Houston, Texas, 77040, United States|Investigational Site Number 8408017, Houston, Texas, 77058, United States|Investigational Site Number 8408036, Houston, Texas, 77061, United States|Investigational Site Number 8408022, Houston, Texas, 77099, United States|Investigational Site Number 8408029, Katy, Texas, 77450, United States|Investigational Site Number 8408054, McAllen, Texas, 78504, United States|Investigational Site Number 8408039, Mesquite, Texas, 75149, United States|Investigational Site Number 8408042, Plano, Texas, 75024, United States|Investigational Site Number 8408011, San Antonio, Texas, 78229-3818, United States|Investigational Site Number 8408041, Schertz, Texas, 78154, United States|Investigational Site Number 8408007, Bountiful, Utah, 84010-7717, United States|Investigational Site Number 8408026, Holladay, Utah, 84117, United States|Investigational Site Number 8408006, Burke, Virginia, 22015, United States|Investigational Site Number 8408004, Manassas, Virginia, 20110, United States|Investigational Site Number 1008011, Gabrovo, 5300, Bulgaria|Investigational Site Number 1008006, Plovdiv, 4000, Bulgaria|Investigational Site Number 1008001, Plovdiv, 4002, Bulgaria|Investigational Site Number 1008005, Ruse, 7002, Bulgaria|Investigational Site Number 1008007, Ruse, 7003, Bulgaria|Investigational Site Number 1008002, Smolyan, 4700, Bulgaria|Investigational Site Number 1008008, Sofia, 1606, Bulgaria|Investigational Site Number 1008012, Sofia, 1632, Bulgaria|Investigational Site Number 1008003, Stara Zagora, 6000, Bulgaria|Investigational Site Number 1008010, Stara Zagora, 6000, Bulgaria|Investigational Site Number 1008004, Varna, 9000, Bulgaria|Investigational Site Number 1248001, Brampton, L6T 0G1, Canada|Investigational Site Number 1248007, Burlington, L7M 4Y1, Canada|Investigational Site Number 1248003, Newmarket, L3Y 5G8, Canada|Investigational Site Number 1248010, Quebec, G1N 4V3, Canada|Investigational Site Number 1248009, Sherbrooke, J1L 0H8, Canada|Investigational Site Number 1248002, Thornhill, L4J 1W3, Canada|Investigational Site Number 1248004, Toronto, M3M 3E5, Canada|Investigational Site Number 1248011, Toronto, M9W 4L6, Canada|Investigational Site Number 1248005, Vancouver, V5Y 3W2, Canada|Investigational Site Number 1248008, Victoriaville, G6P 6P6, Canada|Investigational Site Number 2038007, Brandys, 250 01, Czechia|Investigational Site Number 2038003, Havirov, 736 01, Czechia|Investigational Site Number 2038004, Krnov, 794 01, Czechia|Investigational Site Number 2038011, Ostrava, 710 00, Czechia|Investigational Site Number 2038006, Pardubice, 530 02, Czechia|Investigational Site Number 2038010, Plzen, 363 01, Czechia|Investigational Site Number 2038005, Prague, 18100, Czechia|Investigational Site Number 2038001, Praha 10 - Uhrineves, 104 00, Czechia|Investigational Site Number 2038009, Praha 1, 110 00, Czechia|Investigational Site Number 2038013, Praha 2, 128 00, Czechia|Investigational Site Number 2038002, Praha 4, 149 00, Czechia|Investigational Site Number 2038008, Praha 9, 190 14, Czechia|Investigational Site Number 2508005, Corbeil-Essonnes, 91106, France|Investigational Site Number 2508006, La Roche Sur Yon, 85925, France|Investigational Site Number 2508007, La Tronche, 38700, France|Investigational Site Number 2508003, Mulhouse, 68100, France|Investigational Site Number 2508002, Nantes Cedex 1, 44093, France|Investigational Site Number 2508001, Paris, 75018, France|Investigational Site Number 2508004, Saint-Mandé, 94160, France|Investigational Site Number 3808010, Catania, 95122, Italy|Investigational Site Number 3808003, Catania, 95123, Italy|Investigational Site Number 3808002, Chieti, 66100, Italy|Investigational Site Number 3808004, Milano, 20122, Italy|Investigational Site Number 3808005, Milano, 20132, Italy|Investigational Site Number 3808009, Pavia, 27100, Italy|Investigational Site Number 3808008, Roma, 00133, Italy|Investigational Site Number 3808001, Roma, 00168, Italy|Investigational Site Number 3808007, Roma, 161, Italy|Investigational Site Number 3808011, San Giovanni Rotondo, 71013, Italy|Investigational Site Number 3808006, Siena, 53100, Italy|Investigational Site Number 4288004, Kuldiga, 3301, Latvia|Investigational Site Number 4288008, Limbazi, 4000, Latvia|Investigational Site Number 4288003, Ogre, 5001, Latvia|Investigational Site Number 4288007, Riga, LV -1021, Latvia|Investigational Site Number 4288001, Riga, LV-1002, Latvia|Investigational Site Number 4288002, Riga, LV-1011, Latvia|Investigational Site Number 4288006, Sigulda, LV-2150, Latvia|Investigational Site Number 4288005, Talsi, LV-3200, Latvia|Investigational Site Number 4848002, Chihuahua, 31200, Mexico|Investigational Site Number 4848003, Cuernavaca, 62250, Mexico|Investigational Site Number 4848007, Durango, Durango, 34080, Mexico|Investigational Site Number 4848011, Mexico City, 06700, Mexico|Investigational Site Number 4848005, Monterrey, 07960-6136, Mexico|Investigational Site Number 4848001, Monterrey, 64020, Mexico|Investigational Site Number 4848012, Monterrey, 64460, Mexico|Investigational Site Number 6438008, Chelyabinsk, 454047, Russian Federation|Investigational Site Number 6438006, Dzerzhinsky, 140091, Russian Federation|Investigational Site Number 6438009, Kemerovo, 650002, Russian Federation|Investigational Site Number 6438010, Novosibirsk, 630091, Russian Federation|Investigational Site Number 6438013, Saint-Petersburg, 190013, Russian Federation|Investigational Site Number 6438003, Saint-Petersburg, 192012, Russian Federation|Investigational Site Number 6438002, Saint-Petersburg, 194358, Russian Federation|Investigational Site Number 6438005, Saint-Petersburg, 195213, Russian Federation|Investigational Site Number 6438001, Saint-Petersburg, 196601, Russian Federation|Investigational Site Number 6438012, Saratov, 410054, Russian Federation|Investigational Site Number 6438014, St. Petersburg, 194354, Russian Federation|Investigational Site Number 6438015, Volgograd, 400001, Russian Federation|Investigational Site Number 6438007, Vsevolozhsk, 188643, Russian Federation|Investigational Site Number 6438011, Yaroslavl, 150002, Russian Federation|Investigational Site Number 7038005, Bardejov, 085 01, Slovakia|Investigational Site Number 7038009, Bratislava, 8210, Slovakia|Investigational Site Number 7038001, Kosice, 4014, Slovakia|Investigational Site Number 7038006, Lucenec, 984 01, Slovakia|Investigational Site Number 7038008, Nove Zamky, 940 01, Slovakia|Investigational Site Number 7038004, Povazska Bystrica, 1701, Slovakia|Investigational Site Number 7038002, Roznava, 048 01, Slovakia|Investigational Site Number 7038007, Sabinov, 08301, Slovakia|Investigational Site Number 7038003, Vrutky, 038 61, Slovakia|Investigational Site Number 7248006, Barcelona, 8035, Spain|Investigational Site Number 7248002, Córdoba, 14011, Spain|Investigational Site Number 7248005, Malaga Malaga, 29006, Spain|Investigational Site Number 7248010, Santa Coloma De Gramenet, 08923, Spain|Investigational Site Number 7248009, Santiago De Compostela, 15706, Spain|Investigational Site Number 7248004, Sevilla, 41010, Spain|Investigational Site Number 7248008, Sevilla, 41013, Spain|Investigational Site Number 7248001, Sevilla, 41071, Spain|Investigational Site Number 7248003, Valencia Valencia, 46014, Spain|Investigational Site Number 7248007, Zaragoza, 50009, Spain|Investigational Site Number 8268008, Darlington, DL3 6HX, United Kingdom|Investigational Site Number 8268004, Dundee, DD1 9SY, United Kingdom|Investigational Site Number 8268006, Exeter, EX2 5DW, United Kingdom|Investigational Site Number 8268001, Hull, HU3 2RW, United Kingdom|Investigational Site Number 8268002, Huntingdon, PE29 6NT, United Kingdom|Investigational Site Number 8268007, Sheffield, S5 7AU, United Kingdom|Investigational Site Number 8268003, Southampton, SO30 3JB, United Kingdom|Investigational Site Number 8268005, Wolverhampton, WV10 0QP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03351478

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress