Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT02162550|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2014
Last Update Posted : June 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Bydureon Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||September 2019|
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
- Change in carotid plaque volume [ Time Frame: 18 months ]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 ]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 ]To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162550
|United States, Arizona|
|Phoenix VA Health Care System|
|Phoenix, Arizona, United States, 85012|
|Principal Investigator:||Peter D Reaven, MD||Carl T. Hayden Medical Research Foundation|