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

Approximately 300 subjects with inadequately controlled T2DM on metformin will be recruited
from the United States and Japan. Subjects will be randomly assigned to receive bexagliflozin
tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks.
Subjects will continue to take metformin for the duration of the study. The study will also
enroll 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label
bexagliflozin tablets, 20 mg, for 24 weeks.

Inclusion Criteria:

- Diagnosis of T2DM

- Currently taking metformin as the sole anti-diabetic medication

- Body Mass Index (BMI) ≤ 45 kg/m2

Exclusion Criteria:

- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

- History of genitourinary tract infections

- Evidence of abnormal liver function

- Myocardial infarction, stroke or hospitalization for heart failure within 3 months of
screening

- Pregnant or nursing