Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetic Patients With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in serum levels of Interleukin 6 (IL-6)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vildagliptin+metformin
Oral Vildagliptin+metformin combination
干预措施: Metformin plus vildagliptin (Drug)
Metformin only
Oral metformin only
干预措施: Metformin only (Drug)
结局指标
主要结局
Reduction in serum levels of Interleukin 6 (IL-6)
时间窗: 3 months
次要结局
- Improvement in other markers of athero-thrombosis and inflammation:(3 months)
研究者
Dr. Robert Klempfner Heart Rehabilitation Institute
Robert Klempfner MD
Sheba Medical Center