The Comparative Study of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on the Effect of Improving Glucose Variability and Oxidative Stress in Type 2 Diabetic Patients With Inadequate Glycemic Control on Metformin
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glucose variability
研究概览
简要总结
This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin
详细描述
Sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. Based on this assumption, this research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes
- •duration of diabetes less than 10 years
- •HbA1c 6.5-8.0%
- •BMI 20-30
- •on stable dose of metformin (more than 1000mg) for at least 2 months
排除标准
- •having oral hypoglycemic agents other than metformin
- •using insulin
- •serum creatinin >= 1.5 mg/dL
- •SGOT, SGPT >= 90
- •ischemic heart disease
- •congestive heart failure (NYHA class >=2)
- •severe diabetic complication (PDR, CRF, CVA)
- •on medication affecting glucose profile (such as steroid)
- •infectious disease
- •malignancy
- •pregnant or breast-feeding woman
研究组 & 干预措施
1
Sitagliptin
干预措施: Sitagliptin (Drug)
2
Glimepiride
干预措施: Glimepiride (Drug)
结局指标
主要结局
Glucose variability
时间窗: 1 month
次要结局
- oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)(1 month)