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

Sheba Medical Center

Status and phase

Completed

Phase 4

Conditions

Ischemic Heart Disease

Type 2 Diabetes Mellitus

Treatments

Drug: Metformin plus vildagliptin

Drug: Metformin only

Study type

Interventional

Funder types

Other

Identifiers

NCT01604213

SHEBA-12-9455-RK-CTIL

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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