Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
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|ClinicalTrials.gov Identifier: NCT02769481|
Recruitment Status : Completed
First Posted : May 11, 2016
Results First Posted : May 27, 2021
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Bexagliflozin Drug: Placebo for Bexagliflozin Drug: Glimepiride Drug: Placebo for Glimepiride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin|
|Actual Study Start Date :||August 15, 2016|
|Actual Primary Completion Date :||June 14, 2019|
|Actual Study Completion Date :||June 14, 2019|
Active Comparator: Bexagliflozin
Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
20 mg, tablet
Other Name: EGT0001442
Drug: Placebo for Glimepiride
inactive capsules to match active comparator glimepiride
Active Comparator: Glimepiride
Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
Drug: Placebo for Bexagliflozin
inactive tablet to match active comparator bexagliflozin
2, 4 or 6 mg, capsule
- Change From Baseline in HbA1c at Week 60 [ Time Frame: Baseline and 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).
- Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2 [ Time Frame: Baseline and 60 weeks ]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.
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg [ Time Frame: Baseline and 60 weeks ]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.
- Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks [ Time Frame: During the 96 week treatment period ]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.
- Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60. [ Time Frame: Baseline to 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769481
|Study Director:||J. Paul Lock, MD||Theracos Sub, LLC|