Phase 3
Completed N=1,700
Bexagliflozin Efficacy and Safety Trial
Source: ClinicalTrials.gov NCT02558296 ↗Enrolled (actual)
1,700
Serious AEs
34.2%
Results posted
Jul 2021
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -0.85; -0.37 percentage of glycated hemoglobin — p=<0.0001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.
The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-0.85; -0.37 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin |
-0.84; -0.32 | <0.0001 sig |
| SECONDARY Change in Body Weight From Baseline to Week 48 |
-3.03; -0.38 | <0.0001 sig |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline |
-9.83; -6.87 | 0.0112 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of T2DM
- Subjects who have had a stable treatment regimen for T2DM for the past 3 months
- Subjects who present with at least one of the following 3 histories:
Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems
Exclusion Criteria
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- History of genitourinary tract infections
- Evidence of abnormal liver function
- History of MI, stroke or hospitalization for heart failure in the past 3 months
- Prior kidney transplant or evidence of kidney problems
- Prior or planned pace maker implantation
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02558296). 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.