Phase 3
Completed N=210
Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02715258 ↗Enrolled (actual)
210
Serious AEs
1.0%
Results posted
Apr 2021
Primary outcomePrimary: Change in HbA1c From Baseline at Week 24 — -0.51; -0.10 % of HbA1c — p=0.0012
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline at Week 24 |
-0.51; -0.10 | 0.0012 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline at Week 24 |
-0.60; 1.54 | 0.2340 |
| SECONDARY Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2 |
-1.85; -1.06 | 0.1222 |
Eligibility Criteria
The study population included:
- Male or female adult subjects ≥ 18 years of age at screening
- Subjects who were treatment naïve or receiving 1 OHA in combination with diet and exercise
- Subjects with a diagnosis of T2DM
- Subjects with HbA1c levels at screening between 7.0% and 10.5% (inclusive) if treatment-naïve or with HbA1c levels between 6.5 and 10.0% (inclusive) if on 1 oral anti diabetic agent
- Subjects with a BMI ≤ 45 kg/m2
- Subjects whose doses of medications for hypertension or hyperlipidemia (if applicable) had not changed for at least 30 days prior to screening
- Subjects who were willing and able to return for all clinic visits and to complete all study required procedures
- Female subjects of childbearing potential who were willing to use an adequate method of contraception and not become pregnant for the duration of the study.
- Subjects who maintained glycemic control throughout washout, if applicable.
- Subjects who had HbA1c levels between 7.0 and 10.5% prior to randomization
- Subjects who had been compliant in investigational product administration by missing no more than 1 dose of run-in medication
Subjects who met any of the following criteria were excluded from the study:
- A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
- Use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs at the time of screening
- Female subjects who were pregnant or breastfeeding
- Hemoglobinopathy or carrier status for hemoglobin alleles that affected HbA1c measurement
- Genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening
- Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), 160 mm Hg or diastolic blood pressure > 95 mm Hg at screening
- A positive result for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV)
- History of alcohol or illicit drug abuse in the past 2 years
- Known human immunodeficiency virus (HIV) positive based on medical history
- Life expectancy 2000 mg/g at screening).
Data sourced from ClinicalTrials.gov (NCT02715258). 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.