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Clinical Trial Details

Trial ID: L2272
Source ID: NCT03066830
Associated Drug: Sotagliflozin (Sar439954)
Title: Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03066830/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: Placebo|DRUG: Metformin|DRUG: Sulfonylurea
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26, Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis., Baseline to Week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis., Baseline to Week 26|Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg, Missing data are imputed using the washout imputation method under the missing, not at random framework. An ANCOVA model was used for the analysis., Baseline to Week 12|Change From Baseline in SBP at Week 12 for All Participants, Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis., Baseline to Week 12|Change From Baseline in Body Weight at Week 26, Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis., 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 | 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: 507
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-02-24
Completion Date: 2019-04-30
Results First Posted: 2021-05-11
Last Update Posted: 2021-05-11
Locations: Investigational Site Number 8403003, Litchfield Park, Arizona, 85340, United States|Investigational Site Number 8403018, Peoria, Arizona, 85381, United States|Investigational Site Number 8403009, Greenbrae, California, 94904, United States|Investigational Site Number 8403012, Huntington Park, California, 90255, United States|Investigational Site Number 8403019, Los Angeles, California, 90057, United States|Investigational Site Number 8403034, Montclair, California, 91763, United States|Investigational Site Number 8403016, Spring Valley, California, 91978, United States|Investigational Site Number 8403014, Tustin, California, 92780, United States|Investigational Site Number 8403001, Northglenn, Colorado, 80234, United States|Investigational Site Number 8403029, Bradenton, Florida, 34201, United States|Investigational Site Number 8403004, New Port Richey, Florida, 34652, United States|Investigational Site Number 8403020, North Miami Beach, Florida, 33162, United States|Investigational Site Number 8403026, Ocoee, Florida, 34761, United States|Investigational Site Number 8403032, Orlando, Florida, 32810, United States|Investigational Site Number 8403008, Palm Harbor, Florida, 34684, United States|Investigational Site Number 8403006, Pembroke Pines, Florida, 33026, United States|Investigational Site Number 8403013, Port Charlotte, Florida, 33952, United States|Investigational Site Number 8403007, Nampa, Idaho, 83686, United States|Investigational Site Number 8403011, Flint, Michigan, 48532, United States|Investigational Site Number 8403025, Richfield, Minnesota, 55432, United States|Investigational Site Number 8403021, Henderson, Nevada, 89014, United States|Investigational Site Number 8403028, Greensboro, North Carolina, 27408, United States|Investigational Site Number 8403015, Shelby, North Carolina, 28150, United States|Investigational Site Number 8403033, Hatboro, Pennsylvania, 19040, United States|Investigational Site Number 8403030, Kingsport, Tennessee, 37660, United States|Investigational Site Number 8403002, Dallas, Texas, 75230, United States|Investigational Site Number 8403022, Houston, Texas, 77081, United States|Investigational Site Number 8403005, Burke, Virginia, 22015, United States|Investigational Site Number 1003003, Plovdiv, 4002, Bulgaria|Investigational Site Number 1003002, Ruse, 7002, Bulgaria|Investigational Site Number 1003004, Sofia, 1784, Bulgaria|Investigational Site Number 2333003, Parnu, 8001, Estonia|Investigational Site Number 3483001, Balatonfüred, 8230, Hungary|Investigational Site Number 3483007, Budapest, 1033, Hungary|Investigational Site Number 3483008, Budapest, 1036, Hungary|Investigational Site Number 3483010, Budapest, 1036, Hungary|Investigational Site Number 3483004, Budapest, 1106, Hungary|Investigational Site Number 3483006, Budapest, 1213, Hungary|Investigational Site Number 3483011, Gyula, 5700, Hungary|Investigational Site Number 3483009, Hatvan, 3000, Hungary|Investigational Site Number 3483005, Kecskemet, 6000, Hungary|Investigational Site Number 3483003, Pécs, 7623, Hungary|Investigational Site Number 3483012, Zalaegerszeg, 8900, Hungary|Investigational Site Number 4103001, Goyang-Si, Gyeonggi-Do, 10380, Korea, Republic of|Investigational Site Number 4103011, Guri-Si, Gyeonggi-Do, 11923, Korea, Republic of|Investigational Site Number 4103003, Seongnam-Si, Gyeonggi-Do, 13620, Korea, Republic of|Investigational Site Number 4103007, Seoul, 06591, Korea, Republic of|Investigational Site Number 4103006, Seoul, 1830, Korea, Republic of|Investigational Site Number 4103010, Seoul, 3722, Korea, Republic of|Investigational Site Number 4103005, Seoul, 7345, Korea, Republic of|Investigational Site Number 4103009, Wonju-Si, Gangwon-Do, 26426, Korea, Republic of|Investigational Site Number 6163005, Gdansk, 80-382, Poland|Investigational Site Number 6163006, Gdynia, 81-537, Poland|Investigational Site Number 6163003, Katowice, 40-040, Poland|Investigational Site Number 6163002, Poznan, 60702, Poland|Investigational Site Number 6163001, Warszawa, 01-192, Poland|Investigational Site Number 6163004, Wroclaw, 50-381, Poland|Investigational Site Number 6423004, Bucuresti, Romania|Investigational Site Number 6423002, Iasi, 700732, Romania|Investigational Site Number 7033006, Bratislava, 831 06, Slovakia|Investigational Site Number 7033001, Bratislava, 851 01, Slovakia|Investigational Site Number 7033002, Bratislava, 851 01, Slovakia|Investigational Site Number 7033004, Malacky, 901 01, Slovakia|Investigational Site Number 7033003, Sturovo, 943 01, Slovakia|Investigational Site Number 7033007, Trencin, 911 01, Slovakia|Investigational Site Number 8043001, Kyiv, 2002, Ukraine|Investigational Site Number 8043003, Kyiv, 3037, Ukraine|Investigational Site Number 8043002, Kyiv, 3049, Ukraine|Investigational Site Number 8263012, Birmingham, B15 2SQ, United Kingdom|Investigational Site Number 8263009, Cardiff, CF15 9SS, United Kingdom|Investigational Site Number 8263007, Glasgow, G20 0SP, United Kingdom|Investigational Site Number 8263008, Hexham, NE46 1QJ, United Kingdom|Investigational Site Number 8263003, Inverness, IV2 3JH, United Kingdom|Investigational Site Number 8263014, Liverpool, L22 0LG, United Kingdom|Investigational Site Number 8263011, Manchester, M15 6SE, United Kingdom|Investigational Site Number 8263010, Reading, RG2 0TG, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03066830

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