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

NCT01928329 | Completed Phase 2 Results DMC

• 1 other identifier: 1307012371
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 8

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)

Conditions

Type I Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c Levels

  6 months

Secondary Outcomes (3)

• Change From Baseline in HbA1c Levels

  12 months

• Major Hypoglycemic Event Rate On Drug

  Up to 6 months

• Major Hypoglycemic Event Rate Off Drug

  Up to 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 mg, 1 per week via subcutaneous placebo self injection

Drug: Placebo

Exenatide (Bydureon)

EXPERIMENTAL

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

Drug: Exenatide (Bydureon®)

Interventions

Exenatide (Bydureon®) DRUG

Exenatide (Bydureon)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (8)

University of California, San Francisco

San Francisco, California, United States

Location

Barbara Davis Center

Aurora, Colorado, United States

Location

Yale University

New Haven, Connecticut, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Kevan Herold, MD
• Organization: C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology)

kevan.herold@yale.edu

(203) 785-6507

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 23, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2019
• Last Updated: March 19, 2020
• Results First Posted: October 22, 2019

Record last verified: 2020-03

Locations

US (8)