| Trial ID: | L4426 |
| Source ID: | NCT01604213
|
| Associated Drug: |
Metformin Plus Vildagliptin
|
| Title: |
Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease
|
| Acronym: |
VAAST
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Ischemic Heart Disease
|
| Interventions: |
DRUG: Metformin plus vildagliptin|DRUG: Metformin only
|
| Outcome Measures: |
Primary: Reduction in serum levels of Interleukin 6 (IL-6), 3 months | Secondary: Improvement in other markers of athero-thrombosis and inflammation:, I. Improvement in other markers of athero-thrombosis and inflammation: 1. High sensitivity C-reactive protein (hs-CRP), 2. Platelet reactivity 3. Adiponectin levels 4. IL-1 beta 5. Matrix metallo-peptidase 9 (MMP-9) 6. Additional exploratory markers including: IL-1 alpha ,, IL-17, TNF-alpha, MCP-1, 3 months
|
| Sponsor/Collaborators: |
Sponsor: Sheba Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2016-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-19
|
| Locations: |
Sheba Medical Center, Cardiac Rehabilitation Institute, Tel Hashomer, 52621, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT01604213
|
