A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

Inclusion Criteria

• Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria.
• Diagnosis of T1DM at least 2 years from Visit 0
• Insulin Requirement of ≤ 0.90 units/kg
• Absence of ketoacidosis in the past 6 months
• HbA1c of ≥ 6.5% and ≤ 9.5%
• Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period
• Signed informed consent

Exclusion Criteria

• Inability or unwillingness to give informed consent
• Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.
• Known hypersensitivity to Exenatide, Liraglutide or any product component.
• Participation in an investigational treatment trial within the last 6 weeks before enrollment.
• 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.
• Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis.
• Known severe renal impairment, end-stage renal disease or renal transplantation.
• Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.
• Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.
• Clinically active serious infection.
• Positive pregnancy test in menstruating women or lactating females.
• Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.