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

Sponsor

Phoenix VA Health Care System (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT02162550

Collaborator

(none)

148

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Bydureon Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in carotid plaque volume [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.

Secondary Outcome Measures

Change in reactive hyperemic index [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.
Change in carotid plaque composition [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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