The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery disease who undergo cardiac rehabilitation. The pre-specified established biological markers of inflammation, pro-thrombogenicity, and atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP, platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.
The study is designed as a single-center, randomized, non-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. We plan to prospectively enroll 60 patients with proven coronary artery disease and randomize them in a 2:1 ratio to either vildagliptin-metformin therapy (n=40) or metformin therapy (n=20).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary
Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated
Sheba Medical Center, Cardiac Rehabilitation Institute
Tel Litwinsky, Israel
Reduction in serum levels of Interleukin 6 (IL-6)
Time frame: 3 months
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
Time frame: 3 months
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