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

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