NCT01604213

Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease

Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetic Patients With Coronary Artery Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Type 2 Diabetes Mellitus
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Metformin plus vildagliptin	Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary
DRUG	Metformin only	Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-05-23
• Last updated: 2016-04-19

Locations

1 site across 1 country: Israel