Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes

Inclusion Criteria

• -patients are eligible to be included in the study only if they meet all of the following criteria:
• -are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm
• - have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria
• - have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit
• - have fasting C-peptide >0.6 ng/mL
• - have HbA1c between 6.5% and 10.5%, inclusive.
• Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:
• -diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient’s medical record, which includes laboratory determinations consistent with one or more of the following in the patient’s medical history
• - fasting blood glucose 126 mg/dL (7.0 mmol/L)
• - random blood glucose 200 mg/dL (11.1 mmol/L)
• - two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L)
• AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).