Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 6/16/2018 |
| Start Date: | June 2014 |
| End Date: | September 2019 |
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.
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.
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.
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.
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
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