Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes

Approximately 210 subjects with inadequately controlled T2DM will be recruited from US and
Canada. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or
placebo in a ratio of 2:1 once daily for 24 weeks.

Inclusion Criteria:

- Subjects with T2DM

- Subjects who are not currently taking medication for diabetes or who are taking only
one oral medication for diabetes

- Subjects whose doses of blood pressure or cholesterol medications (if applicable) have
not changed for at least 30 days

Exclusion Criteria:

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

- Current use of injected therapy for treatment of diabetes (insulin or
glucagon-like-peptide-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