| Trial ID: | L6016 |
| Source ID: | NCT02162550
|
| Associated Drug: |
Bydureon
|
| Title: |
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Bydureon|DRUG: placebo
|
| Outcome Measures: |
Primary: Change in carotid plaque volume, To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo., 18 months | Secondary: Change in reactive hyperemic index, 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., 18 months|Change in carotid plaque composition, To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo., 18 months
|
| Sponsor/Collaborators: |
Sponsor: Phoenix VA Health Care System
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
148
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2019-09
|
| Results First Posted: |
|
| Last Update Posted: |
2018-06-14
|
| Locations: |
Phoenix VA Health Care System, Phoenix, Arizona, 85012, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02162550
|
