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

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

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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