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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

Primary Purpose

Type I Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exenatide (Bydureon®)
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco
  • Barbara Davis Center
  • Yale University
  • University of Miami
  • University of Chicago
  • Joslin Diabetes Center
  • University of Michigan
  • SUNY Upstate Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Exenatide (Bydureon)

Arm Description

2 mg, 1 per week via subcutaneous placebo self injection

2 mg, of drug administration 1 per week via subcutaneous self injection

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c Levels

Secondary Outcome Measures

Change From Baseline in HbA1c Levels
Major Hypoglycemic Event Rate On Drug
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
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.

Full Information

First Posted
August 19, 2013
Last Updated
March 17, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01928329
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 mg, 1 per week via subcutaneous placebo self injection
Arm Title
Exenatide (Bydureon)
Arm Type
Experimental
Arm Description
2 mg, of drug administration 1 per week via subcutaneous self injection
Intervention Type
Drug
Intervention Name(s)
Exenatide (Bydureon®)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c Levels
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c Levels
Time Frame
12 months
Title
Major Hypoglycemic Event Rate On Drug
Description
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.
Time Frame
Up to 6 months
Title
Major Hypoglycemic Event Rate Off Drug
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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