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

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ClinicalTrials.gov Identifier: NCT01928329
Recruitment Status : Active, not recruiting
First Posted : August 23, 2013
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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)

Condition or disease Intervention/treatment Phase
Type I Diabetes Drug: Exenatide (Bydureon®) Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Study Start Date : September 2013
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Exenatide

Arm Intervention/treatment
Placebo Comparator: Placebo
2 mg, 1 per week via subcutaneous placebo self injection
Drug: Placebo
Experimental: Exenatide (Bydureon)
2 mg, of drug administration 1 per week via subcutaneous self injection
Drug: Exenatide (Bydureon®)



Primary Outcome Measures :
  1. Change from Baseline in HbA1c Levels [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c Levels [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928329


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States
United States, Connecticut
Yale University
New Haven, Connecticut, United States
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01928329     History of Changes
Other Study ID Numbers: 1307012371
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists