Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

June 12, 2018 updated by: Peter Reaven, Phoenix VA Health Care System

Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis.

Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
  • take stable doses of oral antihyperglycemic agents with or without long-acting insulin
  • must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts

Exclusion Criteria:

  • type 1 diabetes mellitus (T1DM)
  • current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
  • contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
  • screening carotid ultrasound plaque thickness of <0.75 mm, prior or anticipated carotid stenting or endarterectomy
  • recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
  • patients with Multiple Endocrine Neoplasia syndrome type 2
  • serious hypersensitivity to exenatide or any product components
  • severe gastrointestinal disease, or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bydureon
injectable medication Bydureon
Drug: Bydureon
once weekly injection
Other Names:
  • long-acting exenatide
Placebo Comparator: Placebo
a similar looking injectable
Drug: placebo
once weekly injection
Other Names:
  • inactive agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in carotid plaque volume
Time Frame: 18 months
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reactive hyperemic index
Time Frame: 18 months
To determine the effects of long-term Bydureon therapy on vascular function as measured by the difference in fasting and post prandial reactive hyperemic index using peripheral artery tonometry.
18 months
Change in carotid plaque composition
Time Frame: 18 months
To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix VA Health Care System

Investigators

  • Principal Investigator: Peter D Reaven, MD, Carl T. Hayden Medical Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Subject to VA regulation.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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