Clinical Trial Details
| Trial ID: | L3967 |
| Source ID: | NCT02769481 |
| Associated Drug: | Bexagliflozin |
| Title: | Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02769481/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Bexagliflozin|DRUG: Placebo for Bexagliflozin|DRUG: Glimepiride|DRUG: Placebo for Glimepiride |
| Outcome Measures: | Primary: Change From Baseline in HbA1c at Week 60, The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA)., Baseline and Week 60 | Secondary: Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2, Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of body weight in subjects with baseline BMI ≥ 25 kg/m2 at week 60 is analyzed using ANCOVA., Baseline and 60 weeks|Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg, Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of SBP in subjects with baseline SBP ≥ 140 mmHg at week 60 is analyzed using ANCOVA., Baseline and 60 weeks|Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks, The difference in proportion of subjects with ≥ 1 severe or documented symptomatic hypoglycemia events in the bexagliflozin group compared with glimepiride group over 96 weeks is analyzed using a logistic regression model. The full model included region, baseline HbA1c value, background treatment status (metformin or metformin + OHA), eGFR at baseline ≥ 90 or \< 90 mL min 1 per 1.73 m2), treatment as a fixed effect covariate., During the 96 week treatment period|Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60., Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% CI is less than 0., Baseline to Week 60 |
| Sponsor/Collaborators: | Sponsor: Theracos |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 426 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2016-08-15 |
| Completion Date: | 2019-06-14 |
| Results First Posted: | 2021-05-27 |
| Last Update Posted: | 2021-05-27 |
| Locations: | Research Site, Birmingham, Alabama, 35205, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, San Carlos, California, 94070, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Miami Lakes, Florida, 33016, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, West Palm Beach, Florida, 33401, United States|Research Site, Calabash, North Carolina, 28467, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Magnolia, Texas, 77355, United States|Research Site, Aschaffenburg, 63739, Germany|Research Site, Essen, 45277, Germany|Research Site 2, Essen, 45355, Germany|Research Site 2, Hamburg, 21073, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Heidelberg, 69115, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Wangen, 88239, Germany|Research Site, Bochnia, 32-700, Poland|Research Site, Bydgoszcz, 85-312, Poland|Research Site, Kraków, 30-015, Poland|Research Site 2, Kraków, 31-011, Poland|Research Site 2, Lublin, 20-064, Poland|Research Site, Lublin, 20-362, Poland|Research Site, Olsztyn, 10-117, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Puławy, 24-100, Poland|Research Site, Staszów, 28-200, Poland|Research Site, Swarzędz, 62-020, Poland|Research Site, Toruń, 87-100, Poland|Research Site, Warszawa, 00-660, Poland|Research Site, Zamość, 22-400, Poland|Research Site, Łódź, 90-242, Poland|Research Site, Świdnik, 21-040, Poland|Research Site, Alicante, Spain|Research Site 2, Barcelona, Spain|Research Site, Barcelona, Spain|Research Site 2, Madrid, Spain|Research Site 3, Madrid, Spain|Research Site, Madrid, Spain|Research Site 2, Malaga, Spain|Research Site, Malaga, Spain|Research Site 2, Oviedo, Spain|Research Site, Valencia, Spain |
| URL: | https://clinicaltrials.gov/show/NCT02769481 |
