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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes Mellitus Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vildagliptin+metformin

Oral Vildagliptin+metformin combination

Group Type EXPERIMENTAL

Metformin plus vildagliptin

Intervention Type DRUG

Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary

Metformin only

Oral metformin only

Group Type ACTIVE_COMPARATOR

Metformin only

Intervention Type DRUG

Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated

Interventions

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Metformin plus vildagliptin

Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary

Intervention Type DRUG

Metformin only

Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated

Intervention Type DRUG

Other Intervention Names

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Eucreas

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No