Type 2 Diabetes Clinical Trial
Official title:
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.
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. ;
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