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).

Exclusion Criteria-patients will be excluded from the study if they meet any of the
following criteria:

- have previously been exposed to exenatide or, completed or withdrawn from this study
or any other study investigating exenatide

- are unwilling or unable to inject the study medication

- currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone
propionate) daily

- have used oral steroids within the last 60 days or more than 20 days use within the
past year

- have used any weight loss medication(s) within 30 days of screening

- have used insulin for more than 10 weeks during the 3 months prior to screening

- have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males)
or >1.4 mg/dL (123.8 µmol/L) (females)

- have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase
>3.0 times the upper limit of normal (ULN).