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