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)
This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we propose to conduct the trial in adults (\>18 yrs.). Both the subject and the study personnel will be blinded to treatment assignment. The randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis, we propose to determine whether the presence of residual insulin production modifies the drug effect. To do this, we plan to stratify patients for randomization on the basis of detectable C-peptide levels. We will therefore wait for the results of the C-peptide levels from the enrollment MMTT prior to randomization. The study investigators will not be told in which stratum the patient is being randomized and will be blinded to the C-peptide results of the MMTT until the conclusion of the study. Note: The primary and study completion dates were changed 4/2016 to reflect an extension of the recruitment and accrual periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
79
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
Change From Baseline in HbA1c Levels
Time frame: 6 months
Change From Baseline in HbA1c Levels
Time frame: 12 months
Major Hypoglycemic Event Rate On Drug
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.
Time frame: Up to 6 months
Major Hypoglycemic Event Rate Off Drug
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.
Time frame: Up to 12 months
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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