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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Metformin; Vildagliptin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus on oral mono-therapy or diet only treatment

• Stable documented ischemic Heart disease (>30 days post AMI, CABG or PCI)

• Sub-optimal Hb A1c as defined ≥6.5%

• Age > 21

• Life expectancy >1 year

Exclusion Criteria:

• Significant renal impairment (creatinine ≥1.4 mg\dL females or ≥1.5 mg\dL males)

• Planned coronary intervention or planed surgical intervention (PCI or CABG)

• Planned surgical intervention

• Recent (<30 day) acute coronary syndrome (ACS)

• Hypersensitivity to either of the study drug components

• History of lactic acidosis

• Type I diabetes

• Current Hb A1c >9%

• Current Insulin treatment

• Active treatment with GLP-1 or DPP4i medication

• Hepatic impairment or ALT\AST elevations beyond X2 upper normal limit or known hepatic failure

• Inability to comply with study protocol

• Active malignancy other than basal cell carcinoma (BCC)

• Clinically advanced congestive heart failure - NYHA III-IV

• Severe left ventricular dysfunction (LVEF<30%) with NYHA II or any NYHA class with documented recent heart failure decompensation (<3 months)

• Severe stable cardiac angina CCS III - IV or Unstable angina

• Chronic inflammation (i.e. IBD, Lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)

• Pregnancy, lactation or child-bearing potential