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Clinical Trial Details

Trial ID: L1479
Source ID: NCT03242252
Associated Drug: Placebo
Title: Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Acronym: SOTA-CKD3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03242252/results
Conditions: Type 2 Diabetes Mellitus|Chronic Kidney Disease Stage 3
Interventions: DRUG: Placebo|DRUG: Sotagliflozin
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 26, An Analysis of covariance (ANCOVA) model was used for analysis., Baseline to Week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, An ANCOVA model was used for analysis., Baseline to Week 26|Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12, An ANCOVA model was used for analysis., Baseline to Week 12|Change From Baseline in SBP at Week 12 for All Participants, An ANCOVA model was used for analysis., Baseline to Week 12|Change From Baseline in Body Weight at Week 26, An ANCOVA model was used for analysis., Baseline to Week 26|Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g), An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated., Baseline to Week 26|Percentage of Participants With HbA1c <6.5% at Week 26, Week 26|Percentage of Participants With HbA1c <7.0% at Week 26, Week 26|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Up to 60 weeks | 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 60 weeks
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 787
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-16
Completion Date: 2019-10-25
Results First Posted: 2021-06-25
Last Update Posted: 2021-06-25
Locations: Investigational Site Number 8404018, Birmingham, Alabama, 35205, United States|Investigational Site Number 8404045, Guntersville, Alabama, 35976-2206, United States|Investigational Site Number 8404004, Phoenix, Arizona, 85018-2701, United States|Investigational Site Number 8404022, Phoenix, Arizona, 85050-7500, United States|Investigational Site Number 8404007, Little Rock, Arkansas, 72205, United States|Investigational Site Number 8404023, Chula Vista, California, 91910, United States|Investigational Site Number 8404044, Gold River, California, 95670, United States|Investigational Site Number 8404011, Los Angeles, California, 90057, United States|Investigational Site Number 8404003, Norco, California, 92860, United States|Investigational Site Number 8404025, Northridge, California, 91324, United States|Investigational Site Number 8404038, San Dimas, California, 91713, United States|Investigational Site Number 8404019, Clearwater, Florida, 33761, United States|Investigational Site Number 8404001, DeLand, Florida, 32720-0834, United States|Investigational Site Number 8404006, Ocoee, Florida, 34761-4547, United States|Investigational Site Number 8404064, Orlando, Florida, 32806, United States|Investigational Site Number 8404043, Ormond Beach, Florida, 32174-8187, United States|Investigational Site Number 8404013, Palmetto Bay, Florida, 33157-5503, United States|Investigational Site Number 8404016, Savannah, Georgia, 31406, United States|Investigational Site Number 8404040, Wauconda, Illinois, 60084-2452, United States|Investigational Site Number 8404036, Lake Charles, Louisiana, 70601, United States|Investigational Site Number 8404020, New Orleans, Louisiana, 70119-6302, United States|Investigational Site Number 8404014, Norfolk, Nebraska, 68701, United States|Investigational Site Number 8404032, Papillion, Nebraska, 68046-3136, United States|Investigational Site Number 8404048, Hackensack, New Jersey, 07601-1963, United States|Investigational Site Number 8404009, Bronx, New York, 10455, United States|Investigational Site Number 8404074, New York, New York, 00000, United States|Investigational Site Number 8404051, Wilmington, North Carolina, 28401-6638, United States|Investigational Site Number 8404028, Winston-Salem, North Carolina, 27103-3914, United States|Investigational Site Number 8404029, Winston-Salem, North Carolina, 27103-4027, United States|Investigational Site Number 8404026, Dayton, Ohio, 45419-4336, United States|Investigational Site Number 8404052, Lansdale, Pennsylvania, 19446-1002, United States|Investigational Site Number 8404031, Anderson, South Carolina, 29621, United States|Investigational Site Number 8404021, Mount Pleasant, South Carolina, 29464, United States|Investigational Site Number 8404056, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 8404015, Austin, Texas, 78726-4061, United States|Investigational Site Number 8404050, Austin, Texas, 78731, United States|Investigational Site Number 8404060, Austin, Texas, 78749, United States|Investigational Site Number 8404005, Beaumont, Texas, 77702, United States|Investigational Site Number 8404035, Dallas, Texas, 75208, United States|Investigational Site Number 8404039, Houston, Texas, 77058, United States|Investigational Site Number 8404055, Houston, Texas, 77099, United States|Investigational Site Number 8404012, Hurst, Texas, 76054, United States|Investigational Site Number 8404033, Lampasas, Texas, 76550-1820, United States|Investigational Site Number 8404053, McAllen, Texas, 78504, United States|Investigational Site Number 8404057, Round Rock, Texas, 78681, United States|Investigational Site Number 8404059, San Antonio, Texas, 78212, United States|Investigational Site Number 8404010, San Antonio, Texas, 78249-2782, United States|Investigational Site Number 8404008, Layton, Utah, 84041-1200, United States|Investigational Site Number 8404042, Renton, Washington, 98057, United States|Investigational Site Number 8404041, Seattle, Washington, 98105, United States|Investigational Site Number 8404047, Kenosha, Wisconsin, 53144, United States|Investigational Site Number 0324001, Buenos Aires, C1429BWN, Argentina|Investigational Site Number 0324002, Caba, 1425DES, Argentina|Investigational Site Number 0324005, Ciudad Autónoma Buenos Aires, 1205, Argentina|Investigational Site Number 0324008, Cordoba, 5000, Argentina|Investigational Site Number 0324006, Córdoba, X5008HHW, Argentina|Investigational Site Number 0324009, La Plata, 1900, Argentina|Investigational Site Number 0324007, Mar Del Plata, B7600FYK, Argentina|Investigational Site Number 0764007, Belo Horizonte, 30150-240, Brazil|Investigational Site Number 0764001, Belém, 66073-005, Brazil|Investigational Site Number 0764002, Curitiba, 80030-480, Brazil|Investigational Site Number 0764008, Curitiba, 80810-040, Brazil|Investigational Site Number 0764005, Rio De Janeiro, 22271-100, Brazil|Investigational Site Number 0764006, Sao Paulo, 04266-010, Brazil|Investigational Site Number 0764004, São Paulo, 01244-030, Brazil|Investigational Site Number 1244007, Brampton, L6S 0C6, Canada|Investigational Site Number 1244004, Burlington, L7R 1A4, Canada|Investigational Site Number 1244005, Etobicoke, M9R 4E1, Canada|Investigational Site Number 1244006, Laval, H7T 2P5, Canada|Investigational Site Number 1244009, Montreal, H4A 2C6, Canada|Investigational Site Number 1244010, Ottawa, K2J 0V2, Canada|Investigational Site Number 1244003, Thornhill, L4J 8L7, Canada|Investigational Site Number 1244002, Toronto, M4C 5T2, Canada|Investigational Site Number 1244008, Toronto, M4G 3E8, Canada|Investigational Site Number 1244001, Vancouver, V5Y 3W2, Canada|Investigational Site Number 1704008, Barranquilla, 080001, Colombia|Investigational Site Number 1704007, Barranquilla, 80020, Colombia|Investigational Site Number 1704004, Bogota, 110221, Colombia|Investigational Site Number 1704009, Bogota, 110911, Colombia|Investigational Site Number 1704006, Ibague, 730006, Colombia|Investigational Site Number 1704001, Manizales, 170004, Colombia|Investigational Site Number 1704002, Medellin / Antioquia, 50021, Colombia|Investigational Site Number 1704005, Zipaquira, 250252, Colombia|Investigational Site Number 2764001, Frankfurt Am Main, 60596, Germany|Investigational Site Number 2764002, Hamburg, 21073, Germany|Investigational Site Number 2764003, Münster, 48145, Germany|Investigational Site Number 3484008, Baja, 6500, Hungary|Investigational Site Number 3484012, Baja, 6500, Hungary|Investigational Site Number 3484002, Balatonfured, 8230, Hungary|Investigational Site Number 3484007, Budapest, 1033, Hungary|Investigational Site Number 3484011, Debrecen, 4025, Hungary|Investigational Site Number 3484005, Debrecen, 4032, Hungary|Investigational Site Number 3484001, Gyula, 5700, Hungary|Investigational Site Number 3484010, Nyiregyhaza, 4405, Hungary|Investigational Site Number 3484013, Nyregyhza, 4400, Hungary|Investigational Site Number 3484004, Pécs, 7623, Hungary|Investigational Site Number 3764001, Ashkelon, 7830604, Israel|Investigational Site Number 3764010, Be'Er-Sheva, 84101, Israel|Investigational Site Number 3764007, Haifa, 31096, Israel|Investigational Site Number 3764009, Kfar-Saba, 44281, Israel|Investigational Site Number 3764011, Kfar-Saba, 44281, Israel|Investigational Site Number 3764003, Nahariya, 22100, Israel|Investigational Site Number 3764004, Petach Tikva, 49100, Israel|Investigational Site Number 3764006, Ramat Gan, 52621, Israel|Investigational Site Number 3764005, Rehovot, 76100, Israel|Investigational Site Number 3764002, Tel Aviv, 61480, Israel|Investigational Site Number 3764008, Zefat, 13100, Israel|Investigational Site Number 3764013, Zerifin, 70300, Israel|Investigational Site Number 3804007, Catania, 95123, Italy|Investigational Site Number 3804005, Milano, 20122, Italy|Investigational Site Number 3804004, Milano, 20132, Italy|Investigational Site Number 3804008, Naples, 80131, Italy|Investigational Site Number 3804002, Napoli, 80138, Italy|Investigational Site Number 3804003, Roma, 00168, Italy|Investigational Site Number 3804006, Siena, 53100, Italy|Investigational Site Number 4844009, Chihuahua Chihuahua, 31217, Mexico|Investigational Site Number 4844008, Durango, Durango, 34080, Mexico|Investigational Site Number 4844001, Guadalajara, 44210, Mexico|Investigational Site Number 4844003, Guadalajara, 44600, Mexico|Investigational Site Number 4844006, Merida, Yucatan, 97130, Mexico|Investigational Site Number 4844005, Monterrey, 64460, Mexico|Investigational Site Number 4844004, Xalapa, 91020, Mexico|Investigational Site Number 6164002, Białystok, 15-435, Poland|Investigational Site Number 6164006, Katowice, 40-081, Poland|Investigational Site Number 6164010, Krakow, 30-033, Poland|Investigational Site Number 6164009, Krakow, 30-363, Poland|Investigational Site Number 6164004, Krakow, 31-209, Poland|Investigational Site Number 6164008, Krakow, 31-530, Poland|Investigational Site Number 6164011, Lodz, 92-213, Poland|Investigational Site Number 6164005, Oswiecim, 32-600, Poland|Investigational Site Number 6164003, Rzeszow, 35-055, Poland|Investigational Site Number 6164012, Skierniewice, 96-100, Poland|Investigational Site Number 6164007, Warszawa, 02-507, Poland|Investigational Site Number 6424002, Bacau, 600154, Romania|Investigational Site Number 6424001, Bacau, 600238, Romania|Investigational Site Number 6424004, Bucuresti, 010825, Romania|Investigational Site Number 6424009, Bucuresti, 013764, Romania|Investigational Site Number 6424010, Bucuresti, 040172, Romania|Investigational Site Number 6424006, Hunedoara, 331057, Romania|Investigational Site Number 6424011, Oradea, 410159, Romania|Investigational Site Number 6424003, Targu-Mures, 540142, Romania|Investigational Site Number 6434003, Chelyabinsk, 454047, Russian Federation|Investigational Site Number 6434005, Kemerovo, 650002, Russian Federation|Investigational Site Number 6434002, Krasnodar, 3500, Russian Federation|Investigational Site Number 6434004, Novosibirsk, 630091, Russian Federation|Investigational Site Number 6434001, St. Petersburg, 194358, Russian Federation|Investigational Site Number 6434006, Yaroslavl, 150003, Russian Federation|Investigational Site Number 7104008, Cape Town, 7531, South Africa|Investigational Site Number 7104002, Cape Town, 7570, South Africa|Investigational Site Number 7104001, Johannesburg, 1685, South Africa|Investigational Site Number 7104010, Johannesburg, 2188, South Africa|Investigational Site Number 7104005, Johannesburg, 2198, South Africa|Investigational Site Number 7104006, Pretoria, 0002, South Africa|Investigational Site Number 7244011, Barcelona, 08035, Spain|Investigational Site Number 7244007, Granada, 18012, Spain|Investigational Site Number 7244003, Madrid, 28041, Spain|Investigational Site Number 7244006, Palma De Mallorca, 07010, Spain|Investigational Site Number 7244001, Sevilla, 41071, Spain|Investigational Site Number 7244002, Valencia, 46014, Spain|Investigational Site Number 7244009, Zaragoza, 50009, Spain|Investigational Site Number 8044004, Dnipropetrovsk, 49005, Ukraine|Investigational Site Number 8044007, Kharkiv, 61106, Ukraine|Investigational Site Number 8044010, Kharkiv, 61166, Ukraine|Investigational Site Number 8044008, Kiev, 02002, Ukraine|Investigational Site Number 8044003, Kiev, 04050, Ukraine|Investigational Site Number 8044009, Kyiv, 02091, Ukraine|Investigational Site Number 8044001, Kyiv, 03037, Ukraine|Investigational Site Number 8044006, Kyiv, 03049, Ukraine|Investigational Site Number 8044005, Lviv, 79010, Ukraine|Investigational Site Number 8044002, Zaporizhia, 69600, Ukraine
URL: https://clinicaltrials.gov/show/NCT03242252

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress