Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Glycemic variability index
研究概览
简要总结
The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.
详细描述
We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).
Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with type 2 DM
- •with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
- •who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
- •who can be applied with CGMS
排除标准
- •who has liver function abnormality or renal function abnormality
- •who has any kind of diseases, operations, medical treatments that can affect glucose levels
研究组 & 干预措施
Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
干预措施: Glimepiride (Drug)
Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
干预措施: Vildagliptin (Drug)
Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
干预措施: Glimepiride (Drug)
Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Glycemic variability index
时间窗: before and after 3 months of each drug administration
Cardiovascular disease risk factor
时间窗: before and after 3 months of each drug administration
次要结局
- glucose profile and lipid profile(before and after 3 months of each drug administration)
- hypoglycemic index(before and after 3 months of each drug administration)
研究者
Hye Seung Jung
Assistant professor
Seoul National University Hospital