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



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:1/20/2019
Start Date:September 2013
End Date:February 2019

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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.

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.
We found this trial at
8
sites
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Kevan Herold, MD
Phone: 203-785-6507
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Miami, Florida 33124
(305) 284-2211
Phone: 305-243-3781
University of Miami A private research university with more than 15,000 students from around the...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Massimo Pietropaolo, MD
Phone: 734-936-8065
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Aurora, Colorado 80010
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Phone: 671-309-4141
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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San Francisco, California 94143
Phone: 844-813-8273
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750 East Adams Street
Syracuse, New York 13210
Phone: 315-464-9006
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Syracuse, NY
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