Phase 3
Completed N=426
Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
Source: ClinicalTrials.gov NCT02769481 ↗Enrolled (actual)
426
Serious AEs
12.0%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in HbA1c at Week 60 — -0.70; -0.66 percentage of glycated hemoglin
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 60 |
-0.70; -0.66 | — |
| SECONDARY Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2 |
-3.71; 0.59 | < 0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg |
-13.48; -6.95 | 0.0008 sig |
| SECONDARY Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks |
0.02; 0.15 | < 0.0001 sig |
| SECONDARY Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60. |
-0.70; -0.66 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of T2DM
- Currently taking metformin or taking metformin and one additional oral medication for diabetes
- Body Mass Index (BMI) ≤ 45 kg/m2
- Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days
Exclusion Criteria
- Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
- History of genitourinary tract infections
- Evidence of abnormal liver function
- Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
- Prior kidney transplant or evidence of kidney problems
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02769481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.