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Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

T

Theracos

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo for Glimepiride
Drug: Glimepiride
Drug: Bexagliflozin
Drug: Placebo for Bexagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02769481
THR-1442-C-480

Details and patient eligibility

About

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).

Full description

Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

Enrollment

426 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

426 participants in 2 patient groups

Bexagliflozin
Active Comparator group
Description:
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.
Treatment:
Drug: Bexagliflozin
Drug: Placebo for Glimepiride
Glimepiride
Active Comparator group
Description:
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.
Treatment:
Drug: Glimepiride
Drug: Placebo for Bexagliflozin

Trial documents
2

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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