Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Inflammatory biomarkers
研究概览
简要总结
Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and chemokines associated with atherosclerosis/inflammation.
The purpose of this study is to explore the effects of 3 months intervention with DPP-4 inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in circulating monocytes and adipose tissue.
A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic effect of DPP-4 inhibitors beyond glycaemic control alone.
Due to reduced sample size (recruitment problems) the main focus has changed and will now be on cellular aspects and gene regulation (initially secondary outcome measure).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically proven coronary artery disease.
- •HbA1c > 6.5% and under treatment with either metformin and/or glimepiride.
排除标准
- •Allergy or hypersensitivity to any of the drug's components.
- •Heart failure in NYHA class III or IV.
- •Severe liver failure, moderate or severe kidney failure
- •Malignant disease.
- •Active infectious disease.
- •Acute coronary syndrome in the last 3 months.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Saxagliptin
Saxagliptin 5 mg/day
干预措施: Saxagliptin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Inflammatory biomarkers
时间窗: Changes in biomarkers from baseline to 3 months
A selection of biomarkers associated with atherosclerosis, circulating levels and gene expression levels in adipose tissue and leukocytes.
次要结局
- Gene expression of DPP-4 in adipose tissue and leukocytes(Change in expression level of DPP-4 from baseline to 3 months)