Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Efficacy of once daily Metformin XR on 24-h blood glucose control
研究概览
简要总结
There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)
排除标准
- •Pregnancy and lactation
- •Hyperlactatemia (> 2.5 mmol/L)
- •No creatinine levels available since 3 months
- •Severe hepatic insufficiency
- •No liver function parameters available
- •Need of investigation with iodized contrast media
- •Hypersensitivity to metformin
研究组 & 干预措施
normal to mild renal impairment
(12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN
干预措施: Metformin (Drug)
mild to moderate renal impairment
(12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN
干预措施: Metformin (Drug)
moderate to severe renal impairment
(12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN
干预措施: Metformin (Drug)
结局指标
主要结局
Efficacy of once daily Metformin XR on 24-h blood glucose control
时间窗: week 12
The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block).
次要结局
- Tolerability of Metformin XR in mild to moderate (CKD)(week 0, 2, 4, 6, 8, 10 and 12)
- Tolerability of Metformin XR in mild to moderate (CKD) 2(week 0, 2, 4, 6, 8, 10 and 12)