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Keep this study
Lead
Phoenix VA Health Care System
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.
Age
21–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
