Clinical trial NCT01928329: A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Official title: A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type I Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in HbA1c Levels
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in HbA1c Levels
timeFrame: 12 months
measure: Major Hypoglycemic Event Rate On Drug
timeFrame: Up to 6 months
measure: Major Hypoglycemic Event Rate Off Drug
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References: