Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Inclusion Criteria:

• Diagnosis of type 2 diabetes, but otherwise healthy
• HbA1c between 6.6% and 9.5%, inclusive.
• Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
• Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion Criteria:

• Patients previously in a study using exenatide.
• Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
• Treated with insulin within 3 months of screening.