Phase 2
Completed N=292
A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02390050 ↗Enrolled (actual)
292
Serious AEs
1.7%
Results posted
Apr 2021
Primary outcomePrimary: Change in HbA1c After 12 Weeks of Treatment — 0.24; -0.31; -0.44; -0.56 percentage of glycated hemoglobin — p=< 0.0001
Summary
The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c After 12 Weeks of Treatment |
0.24; -0.31; -0.44; -0.56 | < 0.0001 sig |
| SECONDARY Proportion of Subjects With HbA1c < 7% |
11; 15; 16; 27 | 0.1308 |
| SECONDARY Change in Body Weight Over Time |
0.00; -0.74; -0.76; -0.99; 0.02; -1.00 | < 0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) Over Time |
-0.07; -0.55; -0.97; -1.11; 0.11; -0.82 | 0.0002 sig |
| SECONDARY Change in Systolic and Diastolic Blood Pressure Over Time |
-0.14; -0.33; -2.55; -4.39; 0.15; -0.03 | 0.3001 |
| SECONDARY Change in HbA1c Over Time |
-0.00; -0.09; -0.13; -0.13; 0.13; -0.32 | < 0.0001 sig |
Eligibility Criteria
The following subjects were eligible for randomization:
- men or women ≥ 20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test.
- were treatment naïve or taking one oral anti-diabetic medication in combination with diet and exercise
- were diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
- had a body mass index (BMI) ≤ 40 kg/m2
- were taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
- were able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
- were able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
- had an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)
- were capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
Subjects who exhibited any of the following characteristics were to be ineligible for randomization:
- Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
- Used parenteral therapy for treatment of diabetes
- Pregnancy or current breastfeeding status
- Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement
- Genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
- Estimated glomerular filtration rate (eGFR) 2000 mg/g at screening
Data sourced from ClinicalTrials.gov (NCT02390050). 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.