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

• 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: Yale University
• Information provided by (Responsible Party): Yale University

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)

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 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
• Actual Study Completion Date: August 2019

Arms and Interventions

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®)

Outcome Measures

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 ]
2. 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.
3. 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] July 26, 2018

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01928329
• Other Study ID Numbers: 1307012371
• First Posted: August 23, 2013
• Results First Posted: October 22, 2019
• Last Update Posted: March 19, 2020
• Last Verified: March 2020

Additional relevant MeSH terms:

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