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

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Exenatide

Criteria

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.