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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928329
Recruitment Status : Completed
First Posted : August 23, 2013
Results First Posted : October 22, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE August 19, 2013
First Posted Date  ICMJE August 23, 2013
Results First Submitted Date  ICMJE September 3, 2019
Results First Posted Date  ICMJE October 22, 2019
Last Update Posted Date March 19, 2020
Study Start Date  ICMJE September 2013
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
Change From Baseline in HbA1c Levels [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Change From Baseline in HbA1c Levels [ Time Frame: 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
Change From Baseline in HbA1c Levels [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Official Title  ICMJE A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type I Diabetes
Intervention  ICMJE
  • Drug: Exenatide (Bydureon®)
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    2 mg, 1 per week via subcutaneous placebo self injection
    Intervention: Drug: Placebo
  • Experimental: Exenatide (Bydureon)
    2 mg, of drug administration 1 per week via subcutaneous self injection
    Intervention: Drug: Exenatide (Bydureon®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2019)
79
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2013)
120
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928329
Other Study ID Numbers  ICMJE 1307012371
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP