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Clinical Trial Details

Trial ID: L1484
Source ID: NCT03242018
Associated Drug: Placebo
Title: A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Acronym: SOTA-CKD4
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03242018/results
Conditions: Type 2 Diabetes Mellitus|Chronic Kidney Disease Stage 4
Interventions: DRUG: Placebo|DRUG: Sotagliflozin
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo, An analysis of covariance (ANCOVA) model was used for the analysis., Baseline to Week 26 | Secondary: Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo, An ANCOVA model was used for the analysis., Baseline to Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, An ANCOVA model was used for the analysis., Baseline to Week 26|Change From Baseline in Body Weight at Week 26, An ANCOVA model was used for the analysis., Baseline to Week 26|Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg, An ANCOVA model was used for the analysis., Baseline to Week 12|Change From Baseline in SBP at Week 12 for All Participants, An ANCOVA model was used for the analysis., Baseline to Week 12|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), An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP)., First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 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 56.3 weeks
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 277
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-16
Completion Date: 2019-12-11
Results First Posted: 2021-06-25
Last Update Posted: 2021-06-25
Locations: Investigational Site Number 8405033, Guntersville, Alabama, 35976-2206, United States|Investigational Site Number 8405005, Phoenix, Arizona, 85018-2701, United States|Investigational Site Number 8405007, Little Rock, Arkansas, 72205, United States|Investigational Site Number 8405015, Chula Vista, California, 91910, United States|Investigational Site Number 8405032, La Jolla, California, 92037, United States|Investigational Site Number 8405003, Norco, California, 92860-3611, United States|Investigational Site Number 8405013, Northridge, California, 91324, United States|Investigational Site Number 8405018, San Dimas, California, 91773, United States|Investigational Site Number 8405021, Clearwater, Florida, 33761-2022, United States|Investigational Site Number 8405001, DeLand, Florida, 32720-0834, United States|Investigational Site Number 8405043, Miami, Florida, 33155-4630, United States|Investigational Site Number 8405006, Ocoee, Florida, 34761-4547, United States|Investigational Site Number 8405025, Ormond Beach, Florida, 32174-8187, United States|Investigational Site Number 8405039, Lawrenceville, Georgia, 30046, United States|Investigational Site Number 8405041, Arlington Heights, Illinois, 60005-4197, United States|Investigational Site Number 8405030, Sellersburg, Indiana, 47172-8932, United States|Investigational Site Number 8405019, Lake Charles, Louisiana, 70601, United States|Investigational Site Number 8405034, Flint, Michigan, 48532-3447, United States|Investigational Site Number 8405012, Norfolk, Nebraska, 68701-2669, United States|Investigational Site Number 8405035, Albany, New York, 12206, United States|Investigational Site Number 8405014, Bronx, New York, 10455, United States|Investigational Site Number 8405027, Laurelton, New York, 11413, United States|Investigational Site Number 8405037, New Bern, North Carolina, 28562-5200, United States|Investigational Site Number 8405038, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 8405009, Dayton, Ohio, 45419-4336, United States|Investigational Site Number 8405004, Beaumont, Texas, 77702, United States|Investigational Site Number 8405036, Dallas, Texas, 75208, United States|Investigational Site Number 8405020, Houston, Texas, 77058, United States|Investigational Site Number 8405026, Houston, Texas, 77099-4307, United States|Investigational Site Number 8405047, Hurst, Texas, 76054, United States|Investigational Site Number 8405031, San Antonio, Texas, 78215, United States|Investigational Site Number 8405016, San Antonio, Texas, 78249-2782, United States|Investigational Site Number 8405008, Layton, Utah, 84041-1200, United States|Investigational Site Number 8405040, Winchester, Virginia, 22601, United States|Investigational Site Number 0325001, Buenos Aires, C1425DES, Argentina|Investigational Site Number 0325003, Launs Este, B1824KAJ, Argentina|Investigational Site Number 0325004, Mar Del Plata, B7600, Argentina|Investigational Site Number 0765003, Belém, 66073-005, Brazil|Investigational Site Number 0765001, Fortaleza, 60170-195, Brazil|Investigational Site Number 0765004, Rio De Janeiro, 22271-100, Brazil|Investigational Site Number 0765002, Sao Paulo, 01244-030, Brazil|Investigational Site Number 1705004, Barranquilla, 80020, Colombia|Investigational Site Number 1705005, Bogota, 110221, Colombia|Investigational Site Number 1705002, Manizales, 170004, Colombia|Investigational Site Number 1705001, Zipaquira, 250252, Colombia|Investigational Site Number 2765001, Frankfurt Am Main, 60596, Germany|Investigational Site Number 2765003, Hannover, 30625, Germany|Investigational Site Number 2765004, Münster, 48145, Germany|Investigational Site Number 3485005, Baja, 6500, Hungary|Investigational Site Number 3485007, Debrecen, 4032, Hungary|Investigational Site Number 3485004, Pécs, 7624, Hungary|Investigational Site Number 3765002, Ashkelon, 78278, Israel|Investigational Site Number 3765001, Haifa, 31096, Israel|Investigational Site Number 3765007, Kfar-Saba, 44281, Israel|Investigational Site Number 3765005, Ramat Gan, 52621, Israel|Investigational Site Number 3765004, Rehovot, 7642001, Israel|Investigational Site Number 3765003, Tel Aviv, 61480, Israel|Investigational Site Number 3765006, Zefat, 13100, Israel|Investigational Site Number 3805003, Catania, 95123, Italy|Investigational Site Number 3805005, Milano, 20132, Italy|Investigational Site Number 3805006, Napoli, 00181, Italy|Investigational Site Number 3805002, Napoli, 80138, Italy|Investigational Site Number 3805001, Pavia, 27100, Italy|Investigational Site Number 3805004, Roma, 00168, Italy|Investigational Site Number 4845007, Guadalajara Jalisco, 44130, Mexico|Investigational Site Number 4845001, Guadalajara, 44210, Mexico|Investigational Site Number 4845004, Guadalajara, 44600, Mexico|Investigational Site Number 4845008, Merida, Yucatan, 97130, Mexico|Investigational Site Number 4845006, Monterrey, N.L, 64460, Mexico|Investigational Site Number 4845003, Morelia, 58260, Mexico|Investigational Site Number 4845002, Queretaro, 76000, Mexico|Investigational Site Number 4845005, Xalapa, 91020, Mexico|Investigational Site Number 6165003, Krakow, 31-209, Poland|Investigational Site Number 6165002, Lodz, 92-213, Poland|Investigational Site Number 6165004, Oswiecim, 32-600, Poland|Investigational Site Number 6165005, Puławy, 24-100, Poland|Investigational Site Number 6165001, Rzeszow, 35-055, Poland|Investigational Site Number 6425005, Bacau, 600238, Romania|Investigational Site Number 6425002, Bucuresti, 010825, Romania|Investigational Site Number 6425003, Bucuresti, 020475, Romania|Investigational Site Number 6425007, Hunedoara, 331057, Romania|Investigational Site Number 6425004, Lasi, 700503, Romania|Investigational Site Number 6425001, Targu-Mures, 540142, Romania|Investigational Site Number 6435004, Chelyabinsk, 4540, Russian Federation|Investigational Site Number 6435005, Kemerovo, 650002, Russian Federation|Investigational Site Number 6435003, Krasnodar, 350032, Russian Federation|Investigational Site Number 6435006, Novosibirsk, 630091, Russian Federation|Investigational Site Number 6435001, Saint-Petersburg, 194358, Russian Federation|Investigational Site Number 7105003, Cape Town, 7505, South Africa|Investigational Site Number 7105004, Cape Town, 7570, South Africa|Investigational Site Number 7105001, Johannesburg, 2188, South Africa|Investigational Site Number 7105002, Pretoria, 0002, South Africa|Investigational Site Number 7245005, Barcelona, 08035, Spain|Investigational Site Number 7245007, Barcelona, 08036, Spain|Investigational Site Number 7245003, Ferrol, 15405, Spain|Investigational Site Number 7245009, Granada, 18012, Spain|Investigational Site Number 7245006, Madrid, 28041, Spain|Investigational Site Number 7245004, Málaga, 29010, Spain|Investigational Site Number 7245001, Sevilla, 41009, Spain|Investigational Site Number 7245002, Zaragoza, 50009, Spain|Investigational Site Number 8045004, Chernivtsi, 58022, Ukraine|Investigational Site Number 8045006, Kiev, 02002, Ukraine|Investigational Site Number 8045007, Kyiv, 02091, Ukraine|Investigational Site Number 8045003, Kyiv, 04050, Ukraine|Investigational Site Number 8045001, Kyiv, 3037, Ukraine|Investigational Site Number 8045002, Zaporizhzhia, 69600, Ukraine
URL: https://clinicaltrials.gov/show/NCT03242018

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress