Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetic Patients With Coronary Artery Disease
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). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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