Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria:

- At least 18 years old

- Diagnosed with type 2 diabetes mellitus

- HbA1c of 7.1% to 11.0%, inclusive, at screening

- Has stable body weight, i.e., not varying by >3% for at least 3 months prior to
screening

- Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening

- Body mass index of <45 kg/m2 at screening

- Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2
months prior to Visit 1 (Screening)

Exclusion Criteria:

- History of pancreatitis or triglycerides >=500 mg/dL

- Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of
either

- History of renal transplantation, or is currently receiving renal dialysis, or has an
estimated creatinine clearance <50 mL/min

- Active cardiovascular disease

- Presence or history of severe congestive heart failure

- Central nervous system disease, including epilepsy

- Liver disease

- History of severe gastrointestinal diseases

- Clinically significant malignant disease

- Repeated severe hypoglycemia within the last 6 months

- Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog

- Any DPP-4 inhibitor within 3 months prior screening