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Clinical Trial Details

Trial ID: L2878
Source ID: NCT03386344
Associated Drug: Sotagliflozin
Title: Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Acronym: SOTA-BONE
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03386344/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26, An analysis of covariance (ANCOVA) model is used for analysis., Baseline to Week 26 | Secondary: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26, An ANCOVA model is used for analysis., Baseline to Week 26|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26, An ANCOVA model is used for analysis., Baseline to Week 26|Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26, An ANCOVA model is used for analysis., Baseline to Week 26|Change From Baseline in Body Weight at Week 26, An ANCOVA model is used for analysis., Baseline to Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, An ANCOVA model is used for analysis., Baseline to Week 26|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12, An ANCOVA model is used for analysis., Baseline to Week 12|Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26, Week 26|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 106 weeks
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 376
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-19
Completion Date: 2020-05-30
Results First Posted: 2021-06-25
Last Update Posted: 2021-06-25
Locations: Investigational Site Number 8409009, Escondido, California, 92025, United States|Investigational Site Number 8409010, Greenbrae, California, 94904, United States|Investigational Site Number 8409005, Walnut Creek, California, 94598, United States|Investigational Site Number 8409012, Columbus, Georgia, 31904, United States|Investigational Site Number 8409011, Evansville, Indiana, 47714-8011, United States|Investigational Site Number 8409014, Wichita, Kansas, 67205-1138, United States|Investigational Site Number 8409015, Albuquerque, New Mexico, 87106, United States|Investigational Site Number 8409002, Chapel Hill, North Carolina, 27517, United States|Investigational Site Number 8409001, Wilmington, North Carolina, 28401-6638, United States|Investigational Site Number 8409008, Dayton, Ohio, 45419-4336, United States|Investigational Site Number 8409004, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 8409013, Austin, Texas, 78749, United States|Investigational Site Number 8409003, Dallas, Texas, 75230, United States|Investigational Site Number 8409007, Katy, Texas, 77450, United States|Investigational Site Number 0369003, Fremantle, 6160, Australia|Investigational Site Number 0369002, Merewether, 2291, Australia|Investigational Site Number 0369004, Parkville, 3050, Australia|Investigational Site Number 1249003, Brampton, L6S 0C6, Canada|Investigational Site Number 1249008, Etobicoke, M9R 4E1, Canada|Investigational Site Number 1249005, Pointe-Claire, H9R 4S3, Canada|Investigational Site Number 1249006, Thornhill, L4J 1W3, Canada|Investigational Site Number 1249004, Thornhill, L4J 8L7, Canada|Investigational Site Number 1249007, Vancouver, V5Y 3W2, Canada|Investigational Site Number 1249002, Victoriaville, G6P 6P6, Canada|Investigational Site Number 4109006, Daejeon, 35233, Korea, Republic of|Investigational Site Number 4109005, Guri-Si, Gyeonggi-Do, 11923, Korea, Republic of|Investigational Site Number 4109003, Gyeonggi-Do, 13620, Korea, Republic of|Investigational Site Number 4109004, Seoul, 03722, Korea, Republic of|Investigational Site Number 4109001, Seoul, 1830, Korea, Republic of|Investigational Site Number 4849006, Aguascalientes, Aguascalientes, 20230, Mexico|Investigational Site Number 4849001, Aguascalientes, 20129, Mexico|Investigational Site Number 4849003, Cuernavaca, 62250, Mexico|Investigational Site Number 4849002, Guadalajara Jalisco, 44130, Mexico|Investigational Site Number 4849004, Monterrey, 64460, Mexico|Investigational Site Number 4849005, Xalapa, 91020, Mexico|Investigational Site Number 5549004, Auckland, 1309, New Zealand|Investigational Site Number 5549003, Christchurch, 8011, New Zealand|Investigational Site Number 5549001, Rotorua, 3010, New Zealand|Investigational Site Number 5549002, Wellington, 6021, New Zealand|Investigational Site Number 6439007, Kemerovo, 650002, Russian Federation|Investigational Site Number 6439005, Novosibirsk, 630091, Russian Federation|Investigational Site Number 6439002, Saint-Petersburg, 195213, Russian Federation|Investigational Site Number 6439003, Saint-Petersburg, 196601, Russian Federation|Investigational Site Number 6439001, St. Petersburg, 194358, Russian Federation|Investigational Site Number 6439006, Yaroslavl, 150003, Russian Federation|Investigational Site Number 1589005, Changhua, 500, Taiwan|Investigational Site Number 1589008, New Taipei City, 220, Taiwan|Investigational Site Number 1589006, Taichung, 402, Taiwan|Investigational Site Number 1589007, Taichung, 43303, Taiwan|Investigational Site Number 1589001, Tainan, 710, Taiwan|Investigational Site Number 1589002, Tainan, Taiwan|Investigational Site Number 1589004, Taipei, 100, Taiwan|Investigational Site Number 1589003, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT03386344

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress