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

Type I Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928329
• Other study ID #: 1307012371
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: August 2019

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Drug:
• Exenatide (Bydureon®)

• Placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Barbara Davis Center	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	University of California, San Francisco	San Francisco	California
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c Levels		6 months
Secondary	Change From Baseline in HbA1c Levels		12 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 12 months