Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
试验速览
- 阶段
- 4 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reactive hyperemic index to measure endothelial function
研究概览
简要总结
This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.
Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- •Treated with diet and exercise alone for recent 3 months
- •Aged 20-80 years
- •HbA1c 7~9%
- •This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
- •Are not breastfeeding.
- •Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
- •Intend not to become pregnant during the study.
排除标准
- •Previous history of IHD or brain infarct
- •Having typical anginal pain or atypical chest pain with dyspnea
- •Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
研究组 & 干预措施
Metformin first
Metformin first 8 wks --> Dapagliflozin 8wks.
Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day.
干预措施: Metformin (Drug)
Metformin first
Metformin first 8 wks --> Dapagliflozin 8wks.
Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day.
干预措施: Dapagliflozin (Drug)
Dapagliflozin first
Dapagliflozin first 8 wks --> Metformin 8wks.
Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
干预措施: Metformin (Drug)
Dapagliflozin first
Dapagliflozin first 8 wks --> Metformin 8wks.
Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Reactive hyperemic index to measure endothelial function
时间窗: 8 weeks
endothelial function
次要结局
- Urine β2 microglobulin(8 week)
- N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury(8 week)
- Urine albumin excretion ratio(8 week)
研究者
Min Kyong Moon
Associate Professor
Seoul National University Hospital