- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928329
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States
- University of California, San Francisco
-
-
Colorado
-
Aurora, Colorado, United States
- Barbara Davis Center
-
-
Connecticut
-
New Haven, Connecticut, United States
- Yale University
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Illinois
-
Chicago, Illinois, United States
- University of Chicago
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105
- University of Michigan
-
-
New York
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
2 mg, 1 per week via subcutaneous placebo self injection
|
|
EXPERIMENTAL: Exenatide (Bydureon)
2 mg, of drug administration 1 per week via subcutaneous self injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in HbA1c Levels
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c Levels
Time Frame: 12 months
|
12 months
|
|
Major Hypoglycemic Event Rate On Drug
Time Frame: Up to 6 months
|
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.
|
Up to 6 months
|
Major Hypoglycemic Event Rate Off Drug
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Exenatide
Other Study ID Numbers
- 1307012371
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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