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

This study is currently recruiting participants.
Verified October 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01604213
First received: May 21, 2012
Last updated: July 29, 2013
Last verified: October 2012

May 21, 2012
July 29, 2013
September 2012
December 2014   (final data collection date for primary outcome measure)
Reduction in serum levels of Interleukin 6 (IL-6) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01604213 on ClinicalTrials.gov Archive Site
Improvement in other markers of athero-thrombosis and inflammation: [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
Same as current
Not Provided
Not Provided
 
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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Ischemic Heart Disease
  • Drug: Metformin plus vildagliptin
    Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary
    Other Name: Eucreas
  • Drug: Metformin only
    Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated
  • Experimental: Vildagliptin+metformin
    Oral Vildagliptin+metformin combination
    Intervention: Drug: Metformin plus vildagliptin
  • Active Comparator: Metformin only
    Oral metformin only
    Intervention: Drug: Metformin only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2015
December 2014   (final data collection date for primary outcome measure)

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 ≥7.0%
  • 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
Both
21 Years and older
No
Contact: Robert V Klempfner, MD 9729 9546281 klempfner@gmail.com
Contact: Robert Klempfner 9729 9546281 klempfner@gmail.com
Israel
 
NCT01604213
SHEBA-12-9455-RK-CTIL
No
Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Robert Klempfner, MD Sheba Medical Center
Sheba Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP