ACTRN12616001248459已完成1 期
A pharmacokinetic study of metformin in patients with stable stage 4 chronic kidney disease and type 2 diabetes
Dr Ajith Dissanayake0 个研究点目标入组 18 人开始时间: 2016年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Type 2 diabetes for at least 2 years
- •2. Haemoglobin A1c between 6 and 11%
- •3. Stable stage 4 chronic kidney disease as defined by estimated glomerular filtration rate of 15-29mls/1.73m2.
排除标准
- •1. Current treatment with metformin
- •2. Previous intolerance to metformin
- •3. Body mass greater than 160kg
- •4. Severe COPD as evidenced by hospitalization for decompensation within 6 months of randomization, chronic treatment with oral steroids
- •5. Unstable CHF needing frequent hospitalisations or frequent adjustment of heart failure medications
- •6. Significant IHD with acute coronary event, and/or CABG, and/or PCI in the previous 60 days.
- •7. Severe liver disease with icterus and plasma bilirubin greater than or equal to 60 micrommol/L, plasma transaminase greater than 3-fold upper limit of normal, albumin less than 25 g/L or coagulopathy.
- •8. Haemoglobin less tha 100 g/L or platelet count less than 80,000/mm3
- •9. Gastrointestinal bleeding in the previous 60 days
- •10. Unstable angina or planned for invasive cardiac investigations in the next 6 months
- •11. Malignancy other than basal cell carcinoma.
- •12. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.
- •13. Pregnant, nursing a child, or planning a pregnancy at the time of this study
研究者
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