Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3868
Source ID: NCT03115112
Associated Drug: Bexagliflozin
Title: Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03115112/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Sitagliptin|DRUG: Placebo for sitagliptin|DRUG: Placebo for bexagliflozin
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 24, The primary efficacy objective is to demonstrate that bexagliflozin is non-inferior to sitagliptin by evaluating the treatment effect on hemoglobin A1c (HbA1c) reduction at week 24 in subjects whose type 2 diabetes mellitus (T2DM) is inadequately controlled by metformin., Baseline to week 24 | Secondary: Change in FPG From Baseline at Week 24, To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in fasting plasma glucose (FPG) at week 24, Baseline to week 24|Change in Body Weight in Subjects With Baseline BMI ≥ 25 kg/m2 at Week 24, To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in body weight in subjects with baseline body mass index (BMI) ≥ 25 kg/m2 at week 24, Baseline to week 24|Change in SBP in Subjects From Baseline at Week 24, To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in systolic blood pressure (SBP) in subjects at week 24, Baseline to week 24
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 386
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-10-12
Completion Date: 2018-10-31
Results First Posted: 2021-06-04
Last Update Posted: 2021-06-22
Locations: Clinical Research Site 1357, Lincoln, California, 95648, United States|Clinical Research Site 1358, Long Beach, California, 90806, United States|Clinical Research Site 1361, San Dimas, California, 91773, United States|Clinical Research Site 1031, Port Orange, Florida, 32127, United States|Clinical Research Site 1271, Chicago, Illinois, 60611, United States|Clinical Research Site 1359, Topeka, Kansas, 66606, United States|Clinical Research Site 1009, Berlin, New Jersey, 08009, United States|Clinical Research Site 1037, Trenton, New Jersey, 08611, United States|Clinical Research Site 1008, Munroe Falls, Ohio, 44262, United States|Clinical Research Site 1360, San Antonio, Texas, 78258, United States|Clinical Research Site 3119, Hodonín, 695 00, Czechia|Clinical Research Site 3123, Mladá Boleslav, 293 01, Czechia|Clinical Research Site 3120, Olomouc, 779 00, Czechia|Clinical Research Site 3112, Praha, 181 00, Czechia|Clinical Research Site 3122, Prostějov, 796 01, Czechia|Clinical Research Site 9102, Balatonfüred, Hungary|Clinical Research Site 9101, Balatongyörök, Hungary|Clinical Research Site 9106, Budapest, Hungary|Clinical Research Site 9107, Szeged, Hungary|Clinical Research Site 9105, Zalaegerszeg, Hungary|Clinical Research Site 9103, Zamardi, Hungary|Clinical Research Site 6031, Chiba, 260-0804, Japan|Clinical Research Site 6037, Chiba, 272-8516, Japan|Clinical Research Site 6042, Chiba, 277-0825, Japan|Clinical Research Site 6040, Fukuoka, 819-0006, Japan|Clinical Research Site 6035, Fukuoka, 819-0168, Japan|Clinical Research Site 6034, Ibaraki, 300-0835, Japan|Clinical Research Site 6039, Ibaraki, 300-1207, Japan|Clinical Research Site 6041, Ibaraki, 306-0232, Japan|Clinical Research Site 6032, Ibaraki, 310-0826, Japan|Clinical Research Site 6036, Shizuoka, 424-0855, Japan|Clinical Research Site 6038, Tochigi, 323-0022, Japan|Clinical Research Site 6033, Ōsaka, 582-0005, Japan|Clinical Research Site 7137, Gdańsk, 80-858, Poland|Clinical Research Site 7144, Kraków, 30-015, Poland|Clinical Research Site 7142, Kraków, 31-209, Poland|Clinical Research Site 7139, Kraków, 31-261, Poland|Clinical Research Site 7141, Kraków, 31-530, Poland|Clinical Research Site 7120, Lublin, 20-362, Poland|Clinical Research Site 7138, Lublin, 20-538, Poland|Clinical Research Site 7131, Olsztyn, 10-117, Poland|Clinical Research Site 7143, Poznań, 60-819, Poland|Clinical Research Site 7140, Poznań, 60-821, Poland|Clinical Research Site 7136, Poznań, 61-655, Poland|Clinical Research Site 7107, Puławy, 24-100, Poland|Clinical Research Site 7128, Toruń, 87-100, Poland|Clinical Research Site 9002, Alicante, 03004, Spain|Clinical Research Site 9016, Almería, 04001, Spain|Clinical Research Site 9005, Alzira, 46600, Spain|Clinical Research Site 9017, Barcelona, 08023, Spain|Clinical Research Site 9013, Barcelona, 08500, Spain|Clinical Research Site 9012, Madrid, 28007, Spain|Clinical Research Site 9011, Sevilla, 41009, Spain|Clinical Research Site 9014, Sevilla, 41013, Spain|Clinical Research Site 9015, Sevilla, Spain|Clinical Research Site 9018, Valencia, 46010, Spain
URL: https://clinicaltrials.gov/show/NCT03115112

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