Clinical trial NCT02162550: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Cardiovascular Disease
Hyperglycemia
Carotid Plaque
Endothelial function
Incretins
Atherosclerosis
Lead sponsor: Phoenix VA Health Care System
Sponsor class: FED
First posted: 2014-06-12
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in carotid plaque volume
timeFrame: 18 months
Secondary outcomes:
measure: Change in reactive hyperemic index
timeFrame: 18 months
measure: Change in carotid plaque composition
timeFrame: 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
Study officials:
affiliation: Carl T. Hayden Medical Research Foundation
name: Peter D Reaven, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.