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Clinical Trial Details

Trial ID: L3489
Source ID: NCT02926950
Associated Drug: Sotagliflozin (Sar439954)
Title: Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02926950/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: Placebo|DRUG: Metformin
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 and Week 26 | Secondary: 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 and Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, An ANCOVA model was used for the analysis., Baseline and Week 26|Change From Baseline in Body Weight at Week 26, An ANCOVA model was used for the analysis., Baseline and Week 26|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg, An ANCOVA model was used for the analysis., Baseline and Week 12|Change From Baseline in SBP at Week 12 for All Participants, An ANCOVA model was used for the analysis., Baseline and 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 | 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 \[typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL\]. Participants may be reported in more than one category., Up to 79 weeks in the treatment period
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 518
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2019-03-22
Results First Posted: 2021-05-11
Last Update Posted: 2021-05-11
Locations: Investigational Site Number 8402003, Birmingham, Alabama, 35205, United States|Investigational Site Number 8402017, Birmingham, Alabama, 35294, United States|Investigational Site Number 8402052, Phoenix, Arizona, 85018, United States|Investigational Site Number 8402056, Canoga Park, California, 91303, United States|Investigational Site Number 8402020, Escondido, California, 92025, United States|Investigational Site Number 8402028, Gold River, California, 95670, United States|Investigational Site Number 8402067, Greenbrae, California, 94904, United States|Investigational Site Number 8402025, Huntington Park, California, 90255, United States|Investigational Site Number 8402051, La Mirada, California, 90638, United States|Investigational Site Number 8402042, Lemon Grove, California, 91945, United States|Investigational Site Number 8402011, Lincoln, California, 95648, United States|Investigational Site Number 8402014, Long Beach, California, 90807, United States|Investigational Site Number 8402066, Long Beach, California, 90807, United States|Investigational Site Number 8402029, Los Angeles, California, 90022, United States|Investigational Site Number 8402041, Los Angeles, California, 90036, United States|Investigational Site Number 8402001, Los Angeles, California, 90057, United States|Investigational Site Number 8402043, San Diego, California, 92103, United States|Investigational Site Number 8402031, San Ramon, California, 94582, United States|Investigational Site Number 8402047, Tarzana, California, 91356, United States|Investigational Site Number 8402009, Boynton Beach, Florida, 33472, United States|Investigational Site Number 8402016, Daytona Beach, Florida, 32117, United States|Investigational Site Number 8402006, Hialeah, Florida, 33012, United States|Investigational Site Number 8402035, Hialeah, Florida, 33012, United States|Investigational Site Number 8402044, Hialeah, Florida, 33012, United States|Investigational Site Number 8402045, Jacksonville, Florida, 32256, United States|Investigational Site Number 8402060, Miami Beach, Florida, 33140-3608, United States|Investigational Site Number 8402026, Miami, Florida, 33126, United States|Investigational Site Number 8402036, Miami, Florida, 33143, United States|Investigational Site Number 8402064, Miami, Florida, 33183, United States|Investigational Site Number 8402007, Miami, Florida, 33185, United States|Investigational Site Number 8402061, Miami, Florida, 33186, United States|Investigational Site Number 8402033, Opa-locka, Florida, 33054, United States|Investigational Site Number 8402039, Orlando, Florida, 32825, United States|Investigational Site Number 8402063, West Palm Beach, Florida, 33406-5854, United States|Investigational Site Number 8402038, Winter Haven, Florida, 33880, United States|Investigational Site Number 8402008, Macon, Georgia, 31210, United States|Investigational Site Number 8402054, Chicago, Illinois, 60607, United States|Investigational Site Number 8402069, Newton, Iowa, 50208, United States|Investigational Site Number 8402022, West Des Moines, Iowa, 50265, United States|Investigational Site Number 8402059, Lexington, Kentucky, 40503, United States|Investigational Site Number 8402068, Baton Rouge, Louisiana, 70808-4124, United States|Investigational Site Number 8402012, Metairie, Louisiana, 70006, United States|Investigational Site Number 8402037, New Orleans, Louisiana, 70119-6302, United States|Investigational Site Number 8402053, New Orleans, Louisiana, 70124, United States|Investigational Site Number 8402021, Rockville, Maryland, 20852, United States|Investigational Site Number 8402062, Omaha, Nebraska, 68114-3755, United States|Investigational Site Number 8402005, Las Vegas, Nevada, 89148, United States|Investigational Site Number 8402018, Greensboro, North Carolina, 27401, United States|Investigational Site Number 8402002, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8402019, Oklahoma City, Oklahoma, 73104, United States|Investigational Site Number 8402015, Eugene, Oregon, 97404-3233, United States|Investigational Site Number 8402058, Lansdale, Pennsylvania, 19446-1002, United States|Investigational Site Number 8402030, Dallas, Texas, 75230, United States|Investigational Site Number 8402050, DeSoto, Texas, 75115, United States|Investigational Site Number 8402010, Fort Worth, Texas, 76164, United States|Investigational Site Number 8402040, Houston, Texas, 77008, United States|Investigational Site Number 8402065, Houston, Texas, 77058, United States|Investigational Site Number 8402057, Houston, Texas, 77079, United States|Investigational Site Number 8402049, Magnolia, Texas, 77355, United States|Investigational Site Number 8402046, Odessa, Texas, 79761, United States|Investigational Site Number 8402013, San Antonio, Texas, 78218, United States|Investigational Site Number 8402004, San Antonio, Texas, 78229, United States|Investigational Site Number 8402023, Schertz, Texas, 78154, United States|Investigational Site Number 8402027, Clinton, Utah, 84015, United States|Investigational Site Number 8402032, Salt Lake City, Utah, 84107, United States|Investigational Site Number 8402024, Virginia Beach, Virginia, 23454, United States|Investigational Site Number 8402034, Seattle, Washington, 98105, United States|Investigational Site Number 1242014, Barrie, L4M 7G1, Canada|Investigational Site Number 1242004, Brampton, L6S 0C6, Canada|Investigational Site Number 1242005, Brampton, L6T 0G1, Canada|Investigational Site Number 1242001, Concord, L4K 4M2, Canada|Investigational Site Number 1242007, Etobicoke, M9R 4E1, Canada|Investigational Site Number 1242010, Levis, G6W 0M5, Canada|Investigational Site Number 1242012, Newmarket, L3Y 5G8, Canada|Investigational Site Number 1242013, Oakville, L6M 1M1, Canada|Investigational Site Number 1242006, Pointe Claire, H9R 4S3, Canada|Investigational Site Number 1242008, Sherbrooke, J1L 0H8, Canada|Investigational Site Number 1242015, Toronto, M3M 3E5, Canada|Investigational Site Number 1242002, Toronto, M4G 3E8, Canada|Investigational Site Number 1242003, Toronto, M9W 4L6, Canada|Investigational Site Number 1242011, Vancouver, V5X 0C4, Canada|Investigational Site Number 3482002, Budapest, 1033, Hungary|Investigational Site Number 3482003, Budapest, 1088, Hungary|Investigational Site Number 3482006, Budapest, 1213, Hungary|Investigational Site Number 3482004, Debrecen, 4025, Hungary|Investigational Site Number 3482001, Esztergom, 2500, Hungary|Investigational Site Number 3482007, Nyiregyhaza, 4400, Hungary|Investigational Site Number 7032001, Bratislava, 851 01, Slovakia|Investigational Site Number 7032005, Bratislava, 851 01, Slovakia|Investigational Site Number 7032003, Malacky, 901 01, Slovakia|Investigational Site Number 7032002, Nitra, 949 11, Slovakia|Investigational Site Number 7032004, Sturovo, 943 01, Slovakia|Investigational Site Number 7032006, Trencin, 911 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT02926950

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