Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM|
- Change in carotid plaque volume [ Time Frame: 18 months ] [ Designated as safety issue: No ]To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
- Change in reactive hyperemic index [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
injectable medication Bydureon
once weekly injection
Other Name: long-acting exenatide
Placebo Comparator: Placebo
a similar looking injectable
once weekly injection
Other Name: inactive agent
Please refer to this study by its ClinicalTrials.gov identifier: NCT02162550
|Contact: Rubin Ramos||602-277-5551 ext 5812||Rubin.Ramos@va.gov|
|Contact: Linda McDonald, RN||602-277-5551 ext 7063||Linda.McDonald@va.gov|
|United States, Arizona|
|Phoenix VA Health Care System||Recruiting|
|Phoenix, Arizona, United States, 85012|
|Principal Investigator: Peter D. Reaven, MD|
|Principal Investigator:||Peter D Reaven, MD||Carl T. Hayden Medical Research Foundation|