Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

Inclusion criteria:

- Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)

- Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).

- Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1
(Screening)

- Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least
6 weeks prior to Screening, in combination with diet and exercise alone or in
combination with:

1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1

2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
(Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the
Screening visit

Exclusion criteria:

- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

- History of, or currently have, acute or chronic pancreatitis, or have triglyceride
concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

- Positive serological test for hepatitis B or hepatitis C