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

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin

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).

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.

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