Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Inclusion Criteria:

• Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
• HbA1c between 7.1% and 11.0%, inclusive.
• Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

Exclusion Criteria:

• Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
• Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
• Have characteristics contraindicating metformin or sulfonylurea use.
• Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
• Have used drugs for weight loss within 1 month of screening.