Bexagliflozin Efficacy and Safety Trial (BEST)

Approximately 130 investigative sites globally are planned to participate in this study.

An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of
cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo
in a ratio of 2:1 in addition to the background anti-diabetic medications.

The study is an event-driven trial. The treatment period will end when the last randomized
subject has completed at least 52 weeks of treatment and a total of at least 134 subjects
have experienced a cardiac event.

Inclusion Criteria:

- Subjects with a diagnosis of T2DM

- Subjects who have had a stable treatment regimen for T2DM for the past 3 months

- Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure
Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently
smoking, reduced kidney function, or cholesterol problems

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

- History of MI, stroke or hospitalization for heart failure in the past 3 months

- Prior kidney transplant or evidence of kidney problems

- Prior or planned pace maker implantation

- Pregnant or nursing