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Clinical Trial Details

Trial ID: L6727
Source ID: NCT03332771
Associated Drug: Sotagliflozin (Sar439954)
Title: Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Acronym: SOTA-GLIM
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03332771/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: Glimepiride|DRUG: Metformin|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c at Week 52, An analysis of covariance (ANCOVA) model was used for the analysis., Baseline, Week 52 | Secondary: Change From Baseline in Hemoglobin A1c at Week 26, An ANCOVA model was used for the analysis., Baseline, Week 26|Change From Baseline in Body Weight at Week 26 and 52, An ANCOVA model was used for the analysis., Baseline, Week 26, Week 52|Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12, An ANCOVA model was used for the analysis., Baseline, Week 12|Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12, An ANCOVA model was used for the analysis., Baseline, Week 12|Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event, Documented symptomatic hypoglycemia includes the typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)., Up to Week 52|Percentage of Participants With Adverse Events (AEs), 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., Up to Week 52 | Other: Percentage of Participants With Hypoglycemic Events, Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\]., Up to Week 52
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 954
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-12-01
Completion Date: 2019-09-06
Results First Posted: 2021-05-11
Last Update Posted: 2021-05-11
Locations: Investigational Site Number 8407040, Birmingham, Alabama, 35205, United States|Investigational Site Number 8407048, Birmingham, Alabama, 35233-2110, United States|Investigational Site Number 8407035, Little Rock, Arkansas, 72211, United States|Investigational Site Number 8407051, Anaheim, California, 92801-2417, United States|Investigational Site Number 8407065, Canoga Park, California, 91301, United States|Investigational Site Number 8407078, Carmichael, California, 95608, United States|Investigational Site Number 8407089, Downey, California, 90242, United States|Investigational Site Number 8407011, Gold River, California, 95670, United States|Investigational Site Number 8407044, Greenbrae, California, 94904, United States|Investigational Site Number 8407006, Huntington Park, California, 90255-2911, United States|Investigational Site Number 8407037, Lemon Grove, California, 91945, United States|Investigational Site Number 8407100, Lomita, California, 90717, United States|Investigational Site Number 8407033, Long Beach, California, 90806, United States|Investigational Site Number 8407019, Los Angeles, California, 90057-3507, United States|Investigational Site Number 8407098, Northridge, California, 91325-5409, United States|Investigational Site Number 8407094, Norwalk, California, 90650, United States|Investigational Site Number 8407106, Pomona, California, 91766, United States|Investigational Site Number 8407096, Rancho Cucamonga, California, 91730, United States|Investigational Site Number 8407036, Sacramento, California, 95821, United States|Investigational Site Number 8407084, Tarzana, California, 91356-3551, United States|Investigational Site Number 8407034, Upland, California, 91786-4070, United States|Investigational Site Number 8407032, Van Nuys, California, 91405, United States|Investigational Site Number 8407004, Walnut Creek, California, 94598, United States|Investigational Site Number 8407117, Wildomar, California, 92595, United States|Investigational Site Number 8407045, Colorado Springs, Colorado, 80920-8075, United States|Investigational Site Number 8407074, Bradenton, Florida, 34201, United States|Investigational Site Number 8407027, Clearwater, Florida, 33761, United States|Investigational Site Number 8407103, Cooper City, Florida, 33024, United States|Investigational Site Number 8407021, Coral Gables, Florida, 33134, United States|Investigational Site Number 8407062, Lake Worth, Florida, 33467, United States|Investigational Site Number 8407121, Ocoee, Florida, 34761, United States|Investigational Site Number 8407024, Orlando, Florida, 32825-4454, United States|Investigational Site Number 8407038, Palmetto Bay, Florida, 33157-5503, United States|Investigational Site Number 8407093, Pembroke Pines, Florida, 33026-3924, United States|Investigational Site Number 8407107, Spring Hill, Florida, 34609, United States|Investigational Site Number 8407091, Tampa, Florida, 33619, United States|Investigational Site Number 8407113, Tampa, Florida, 33634, United States|Investigational Site Number 8407092, West Palm Beach, Florida, 33401, United States|Investigational Site Number 8407115, Winter Haven, Florida, 33880, United States|Investigational Site Number 8407017, Chicago, Illinois, 60607, United States|Investigational Site Number 8407018, Elgin, Illinois, 60124, United States|Investigational Site Number 8407046, Gurnee, Illinois, 60031, United States|Investigational Site Number 8407119, Springfield, Illinois, 62711, United States|Investigational Site Number 8407075, Waterloo, Iowa, 50702, United States|Investigational Site Number 8407120, West Des Moines, Iowa, 50265, United States|Investigational Site Number 8407095, Topeka, Kansas, 66606-2806, United States|Investigational Site Number 8407083, Wichita, Kansas, 67205-1138, United States|Investigational Site Number 8407043, Lexington, Kentucky, 40503-2517, United States|Investigational Site Number 8407087, Lexington, Kentucky, 40503, United States|Investigational Site Number 8407060, Lake Charles, Louisiana, 70601, United States|Investigational Site Number 8407058, New Orleans, Louisiana, 70119, United States|Investigational Site Number 8407009, New Orleans, Louisiana, 70124, United States|Investigational Site Number 8407079, Zachary, Louisiana, 70791-4010, United States|Investigational Site Number 8407085, Baltimore, Maryland, 21237, United States|Investigational Site Number 8407001, Rockville, Maryland, 20852, United States|Investigational Site Number 8407069, Troy, Michigan, 48098-6334, United States|Investigational Site Number 8407110, Olive Branch, Mississippi, 38654, United States|Investigational Site Number 8407054, Bridgeton, Missouri, 63044, United States|Investigational Site Number 8407049, Norfolk, Nebraska, 68701, United States|Investigational Site Number 8407039, Omaha, Nebraska, 68114, United States|Investigational Site Number 8407061, Papillion, Nebraska, 68046-3136, United States|Investigational Site Number 8407108, Las Vegas, Nevada, 89106-4132, United States|Investigational Site Number 8407050, Albuquerque, New Mexico, 87106, United States|Investigational Site Number 8407116, New York, New York, 10016-6402, United States|Investigational Site Number 8407086, New York, New York, 10029, United States|Investigational Site Number 8407122, New York, New York, 10036, United States|Investigational Site Number 8407123, West Seneca, New York, 14224, United States|Investigational Site Number 8407020, Greensboro, North Carolina, 27408, United States|Investigational Site Number 8407114, Lenoir, North Carolina, 28645-8981, United States|Investigational Site Number 8407015, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8407030, Salisbury, North Carolina, 28144-2742, United States|Investigational Site Number 8407041, Wilmington, North Carolina, 28401-6638, United States|Investigational Site Number 8407101, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 8407099, Cincinnati, Ohio, 45245, United States|Investigational Site Number 8407081, Lyndhurst, Ohio, 44124-2467, United States|Investigational Site Number 8407057, Norman, Oklahoma, 73069, United States|Investigational Site Number 8407073, Oklahoma City, Oklahoma, 73104-3252, United States|Investigational Site Number 8407068, Eugene, Oregon, 97404, United States|Investigational Site Number 8407104, Beaver, Pennsylvania, 15009-1957, United States|Investigational Site Number 8407025, Hatboro, Pennsylvania, 19040-2045, United States|Investigational Site Number 8407053, Lansdale, Pennsylvania, 19446-1002, United States|Investigational Site Number 8407016, Charleston, South Carolina, 29407, United States|Investigational Site Number 8407071, Greer, South Carolina, 29651-1817, United States|Investigational Site Number 8407022, Mount Pleasant, South Carolina, 29464, United States|Investigational Site Number 8407031, Mount Pleasant, South Carolina, 29464, United States|Investigational Site Number 8407014, Jefferson City, Tennessee, 37760, United States|Investigational Site Number 8407002, Knoxville, Tennessee, 37938, United States|Investigational Site Number 8407056, Memphis, Tennessee, 38163, United States|Investigational Site Number 8407026, Austin, Texas, 78735-8982, United States|Investigational Site Number 8407029, Beaumont, Texas, 77702, United States|Investigational Site Number 8407070, Carrollton, Texas, 75010, United States|Investigational Site Number 8407102, Corpus Christi, Texas, 78414-4173, United States|Investigational Site Number 8407023, Dallas, Texas, 75230, United States|Investigational Site Number 8407111, Dallas, Texas, 75231, United States|Investigational Site Number 8407013, Fort Worth, Texas, 76164, United States|Investigational Site Number 8407080, Houston, Texas, 77040, United States|Investigational Site Number 8407088, Houston, Texas, 77095-2856, United States|Investigational Site Number 8407090, Katy, Texas, 77450, United States|Investigational Site Number 8407042, Lampasas, Texas, 76550-1820, United States|Investigational Site Number 8407067, Lufkin, Texas, 75904, United States|Investigational Site Number 8407118, Lufkin, Texas, 75904, United States|Investigational Site Number 8407059, McAllen, Texas, 78504, United States|Investigational Site Number 8407012, Mesquite, Texas, 75149, United States|Investigational Site Number 8407007, Plano, Texas, 75075, United States|Investigational Site Number 8407005, San Antonio, Texas, 78218, United States|Investigational Site Number 8407064, San Antonio, Texas, 78229-3818, United States|Investigational Site Number 8407010, Schertz, Texas, 78154, United States|Investigational Site Number 8407076, Splendora, Texas, 77372, United States|Investigational Site Number 8407063, Clinton, Utah, 84015, United States|Investigational Site Number 8407055, Holladay, Utah, 84117-7054, United States|Investigational Site Number 8407097, Ogden, Utah, 84405, United States|Investigational Site Number 8407072, Salt Lake City, Utah, 84102-1553, United States|Investigational Site Number 8407124, Manassas, Virginia, 20110-4421, United States|Investigational Site Number 8407105, Richmond, Virginia, 23249-0001, United States|Investigational Site Number 8407028, Renton, Washington, 98055, United States|Investigational Site Number 1007002, Gabrovo, 5300, Bulgaria|Investigational Site Number 1007008, Plovdiv, 4000, Bulgaria|Investigational Site Number 1007003, Plovdiv, 4002, Bulgaria|Investigational Site Number 1007001, Ruse, 7003, Bulgaria|Investigational Site Number 1007004, Smolyan, 4700, Bulgaria|Investigational Site Number 1007009, Sofia, 1632, Bulgaria|Investigational Site Number 1007005, Stara Zagora, 6000, Bulgaria|Investigational Site Number 1007006, Stara Zagora, 6000, Bulgaria|Investigational Site Number 1007007, Varna, 9000, Bulgaria|Investigational Site Number 3487005, Balatonfured, 8230, Hungary|Investigational Site Number 3487001, Budapest, 1033, Hungary|Investigational Site Number 3487010, Budapest, 1134, Hungary|Investigational Site Number 3487006, Debrecen, 4025, Hungary|Investigational Site Number 3487008, Debrecen, 4032, Hungary|Investigational Site Number 3487002, Kecskemet, 6000, Hungary|Investigational Site Number 3487007, Nyiregyhaza, 4405, Hungary|Investigational Site Number 3487004, Nyíregyháza, 4400, Hungary|Investigational Site Number 7037004, Bardejov, 085 01, Slovakia|Investigational Site Number 7037008, Bratislava, 831 06, Slovakia|Investigational Site Number 7037007, Bratislava, 85101, Slovakia|Investigational Site Number 7037005, Kosice, 4014, Slovakia|Investigational Site Number 7037002, Levice, 934 01, Slovakia|Investigational Site Number 7037010, Nitra, 94901, Slovakia|Investigational Site Number 7037009, Roznava, 048 01, Slovakia|Investigational Site Number 7037001, Sabinov, 08301, Slovakia|Investigational Site Number 7037003, Trnava, 91701, Slovakia|Investigational Site Number 7037006, Vrutky, 038 61, Slovakia
URL: https://clinicaltrials.gov/show/NCT03332771

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details