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临床试验/NCT01404676
NCT01404676已完成4 期

The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week).

研究概览

简要总结

The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic variability, oxidative stress, and endothelial function in patients with type 2 diabetes.

详细描述

Recently, improved understanding of the incretin effect on the pathophysiology of type 2 diabetes has led to development of new agent for hypoglycemic therapy. Vildagliptin is a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that augments the active glucagon-like peptide(GLP)-1 concentration, increases insulin secretion and improves glucose tolerance. Vildagliptin has a similar glucose lowering effect, but lower hypoglycemic events, as compared to glimepiride. Vildagliptin could improve not only the mean glycemic control but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin and glucagon secretion. Furthermore, decreased postprandial glycemic excursion might reduce the oxidative stress markers and improve endothelial dysfunction. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. In addition, GLP-1 and GLP-1 analogues exert direct beneficial effects on endothelium-dependent vasodilatation. Therefore DPP-4 inhibitors may directly improve endothelial dysfunction.

Based on this assumption, this research will focus on the effect of vildagliptin on glycemic variability, oxidative stress markers and endothelial cell function compared to long acting sulfonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%

排除标准

  • 未提供

研究组 & 干预措施

Vildagliptin + Metformin

Experimental

Adding Vildagliptin to metformin users

干预措施: Add Vildagliptin (Drug)

Glimepiride + Metformin

Active Comparator

Adding Glimepiride to metformin users

干预措施: Add Glimepiride (Drug)

结局指标

主要结局

Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week).

时间窗: 0 week and 12 weeks

To compare the effect of vildagliptin based treatment for 12 weeks on glycemic variability with sulfonylurea using continuous glucose monitoring system(CGMS).

次要结局

  • Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks.(0 week and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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