Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- differences of sitagliptin and metformin trough concentration according to genetic variations of transporters
研究概览
简要总结
Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available.
In clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications.
Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly Diagnosed Type 2 Diabetes Patients
- •20-80 years old
- •Taking sitagliptin and metformin for more than 3 months
排除标准
- •Taking other oral hypoglycemic agents
- •Taking medications can induce or inhibit transporters
结局指标
主要结局
differences of sitagliptin and metformin trough concentration according to genetic variations of transporters
时间窗: After 3 months of sitagliptin and metformin treatment
次要结局
- differences of HbA1c change according to genetic variations of transporters(Baseline and after 3 months of sitagliptin and metformin treatment)
研究者
Doo-Yeoun Cho
Assitant Professor
Ajou University School of Medicine