May Metformin be Used in Renal Failure?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
研究概览
简要总结
The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients by stage is considered, 60 patients in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diabetic patients not treated with metformin, no treatment diabetic or have been treated but poorly balanced (HbA1c> 7%) and an applicant building with metformin; at any stage renal stable (stages 1-5 according to the classification MDRD)
- •Patients aged 18 to 80 years;
- •Patients with an assessment of renal function dating back more than 3 months;
- •Patients whose renal function is stable, on the criterion of the absence of fluctuation over 30% of renal function of creatinine clearance in the last three months, a reference to renal function at least 3 months from the balance sheet inclusion is necessary.
排除标准
- •Patient over 80 years
- •Patients incapacitated adults (protected under guardianship)
- •No previous reference creatinine;
- •Fluctuation over 30% of renal function (creatinine clearance) in the three months;
- •Reduction in BMI of more than 5% during the last 3 months;
- •Severe hepatic impairment (Child stage> A);
- •No reference to liver stages 3-5
- •Patients to be an X-ray with injection of contrast.
研究组 & 干预措施
Metformin
Metformin in patients with renal failure
干预措施: Metformin (Drug)
结局指标
主要结局
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
时间窗: Phase 3 : Day 35
the percentage of patients in stage 1 of chronic kidney disease (CKD) each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
时间窗: Phase 4 : Day 49
次要结局
- the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.(Phase3 : Day 35)