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Clinical Trial Details

Trial ID: L6021
Source ID: NCT02390050
Associated Drug: Bexagliflozin Tablets
Title: A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02390050/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Bexagliflozin tablets|DRUG: Bexagliflozin tablets, placebo
Outcome Measures: Primary: Change in HbA1c After 12 Weeks of Treatment, Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes., 12 weeks | Secondary: Proportion of Subjects With HbA1c < 7%, To assess the efficacy of bexagliflozin based on the proportion of subjects who reach the American Diabetes Associate (ADA) and the Japan Diabetes Society target HbA1c of \<7%., Baseline to up to 12 weeks|Change in Body Weight Over Time, The body weight was analyzed on the full analysis set using the MMRM ANCOVA model used for the primary efficacy analysis., Baseline to Week 2, Week 6 and Week 12|Change in Fasting Plasma Glucose (FPG) Over Time, The fasting plasma glucose (FPG) was analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis., Baseline to Week 2, Week 6 and Week 12|Change in Systolic and Diastolic Blood Pressure Over Time, The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis., Baseline to Week 2, Week 6 and Week 12|Change in HbA1c Over Time, The least square mean (LSM) change from baseline to Week 2, Week 6 and Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes. The LSM change was calculated by excluding HbA1c data obtained after rescue medication., Baseline to Week 2, Week 6 and Week 12
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 292
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-05-12
Completion Date: 2016-06-03
Results First Posted: 2021-04-20
Last Update Posted: 2021-06-29
Locations: Phoenix Medical Research Institute LLC, Peoria, Arizona, 85381, United States|Advanced Arizona Clinical Research, Tucson, Arizona, 85712, United States|Hope Clinical Research, LLC, Canoga Park, California, 91303, United States|Catalina Research Institute, Chino, California, 91710, United States|National Research Institute, Huntington Park, California, 90255, United States|Long Beach Clinical Trials, Long Beach, California, 90806, United States|Synergy San Diego, National City, California, 91950, United States|Northern California Research, Sacramento, California, 95821, United States|Artemis Institute for Clinical Research, LLC, San Diego, California, 92103, United States|Infosphere Clinical Research, Inc, West Hills, California, 91307, United States|M&O Clinical Research LLC, Fort Lauderdale, Florida, 33316, United States|AGA Clinical Trials, Hialeah, Florida, 33012, United States|Compass Research North, Leesburg, Florida, 34748, United States|Sweet Hope Research Specialty, Inc, Miami Lakes, Florida, 33016, United States|Sunshine Research Center, Opa-locka, Florida, 33054, United States|Compass Research LLC, Orlando, Florida, 32806, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|PICR Clinic, Atlanta, Georgia, 30338, United States|Sundance Clinical Research, Saint Louis, Missouri, 63141, United States|Premier Research Ltd, Trenton, New Jersey, 08611, United States|Regional Clinical Research, Inc, Endwell, New York, 13760, United States|Calabash Medical Center, Calabash, North Carolina, 28467, United States|Diabetes & Endocrinology Consultants PC, Morehead City, North Carolina, 28557, United States|PMG Research of Salisbury, Salisbury, North Carolina, 28144, United States|CTI Research, Cincinnati, Ohio, 45255, United States|Summit Research Group, LLC, Stow, Ohio, 44224, United States|Columbia Research Group, Inc., Portland, Oregon, 97239, United States|Detweiler Family Medicine and Associate, P.C., Lansdale, Pennsylvania, 19446, United States|North Myrtle Beach Family Practice, Myrtle Beach, South Carolina, 29582, United States|Global Medical Research, DeSoto, Texas, 75115, United States|Rockwood Medical Clinic, Fort Worth, Texas, 76164, United States|Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States|Medical Corporation Hitomi-kai Motomachi Takatsuka Naika Clinic, Yokohama Naka-ku, Kanagawa, 231-0023, Japan|Medical Corporation Hayashi katagihara Clinic, Nishikyo-ku, Kyoto, 615-8125, Japan|Medical Corporation KEISEIKAI Kajiyama clinic, Ukyou-ku, Kyoto, 615-0035, Japan|Ikeoka Medical Corp. Ikeoka Clinic, Joto-ku, Osaka, 536-0008, Japan|Miyauchi Medical Center, Takatsuki-shi, Osaka, 569-1123, Japan|Medical Corporation Senrichuo Ekimae Clinic, Toyonaka-shi, Osaka, 560-0082, Japan|Medical Corporation Segawa Hospital, Hikigun Ogawamachi, Saitama, 355-0328, Japan|Medical Corporation Yukeikai Asano Clinic, Kawagoe-shi, Saitama, 350-0851, Japan|Medical Corporation Ishii Internal Medicine Clinic, Kawaguchi, Saitama, 333-0844, Japan|Medical Corporation Fusanokai Shimizu Clinic Fusa, Saitama-shi, Saitama, 336-0963, Japan|Medical Corp. SEIKOUKAI New Medical Research System Clinic, Hachioji-shi, Tokyo, 192-0046, Japan|Medical Corporation Jototowakai Shinkoiwa ekimae sogo Clinic, Katsushika-ku, Tokyo, 124-0024, Japan|Medical Corporation IHL Pedi Shiodome Medical Clinic, Minato-ku, Tokyo, 105-7390, Japan|Medical Corporation IHL Shinagawa East One Medical Clinic, Minato-ku, Tokyo, 108-0075, Japan|Kenkokan Suzuki Clinic, Ota-ku, Tokyo, 143-0015, Japan|Medical Corporation Souyu-kai Hirahata Clinic, Shibuya-ku, Tokyo, 150-0002, Japan|Medical Corporation Yuhokai Miho-Clinic, Shinagawa-ku, Tokyo, 141-0032, Japan|Ikebukuro Metropolitan Clinic, Toshima-ku, Tokyo, 171-0021, Japan
URL: https://clinicaltrials.gov/show/NCT02390050

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D517 Bexagliflozin small molecule DB12236 Details