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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bydureon
placebo
Sponsored by
Phoenix VA Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Cardiovascular Disease, Hyperglycemia, Carotid Plaque, Endothelial function, Incretins, Atherosclerosis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bydureon

Placebo

Arm Description

injectable medication Bydureon

a similar looking injectable

Outcomes

Primary Outcome Measures

Change in carotid plaque volume
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.

Secondary Outcome Measures

Change in reactive hyperemic index
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.
Change in carotid plaque composition
To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.

Full Information

First Posted
May 27, 2014
Last Updated
June 12, 2018
Sponsor
Phoenix VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02162550
Brief Title
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
Official Title
Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Cardiovascular Disease, Hyperglycemia, Carotid Plaque, Endothelial function, Incretins, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bydureon
Arm Type
Experimental
Arm Description
injectable medication Bydureon
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
a similar looking injectable
Intervention Type
Drug
Intervention Name(s)
Bydureon
Other Intervention Name(s)
long-acting exenatide
Intervention Description
once weekly injection
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
inactive agent
Intervention Description
once weekly injection
Primary Outcome Measure Information:
Title
Change in carotid plaque volume
Description
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in reactive hyperemic index
Description
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.
Time Frame
18 months
Title
Change in carotid plaque composition
Description
To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D Reaven, MD
Organizational Affiliation
Carl T. Hayden Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Subject to VA regulation.
Citations:
PubMed Identifier
33495294
Citation
Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.
Results Reference
derived

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

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