| Trial ID: | L5093 |
| Source ID: | NCT02380521
|
| Associated Drug: |
Exenatide Once Weekly (Bydureon™)
|
| Title: |
Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Exenatide once weekly (BYDUREON™)
|
| Outcome Measures: |
Primary: Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly, Reduction in cIMT after 8 months of the treatment, Change from baseline to 8 months of the treatment | Secondary: Atherogenic lipoproteins (as measured by the analysis of 11 distinct lipoprotein subclasses using the Lipoprint system®) in patients with T2DM treated with exenatide once weekly, Reduction in atherogenic lipoproteins including small dense LDL particles after 8 months of the treatment, Change from baseline to 8 months of the treatment|Oxidative stress (as measured by markers of oxidative stress) in patients with T2DM treated with exenatide once weekly, Reduction in oxidative stress after 8 months of the treatment, Change from baseline to 8 months of the treatment|Endothelial dysfunction (as measured by flow mediated dilation of brachial artery) in patients with T2DM treated with exenatide once weekly, Improvement of endothelial dysfunction as indicated by changes in flow mediated dilation of brachial artery after 8 months of the treatment, Change from baseline to 8 months of the treatment
|
| Sponsor/Collaborators: |
Sponsor: University of Palermo | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2016-11
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-08
|
| Locations: |
University Hospital of Palermo, Palermo, 90127, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02380521
|
