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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type I Diabetes

In brief

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)

Key facts

Study ID

NCT01928329

Run by

Yale University

People needed

79

Starts

2013-09-01

Expected to finish

2019-08-01

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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