NCT01069926已完成1 期
A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline
研究概览
简要总结
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin
- •Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal
排除标准
- •Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
- •Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.
结局指标
主要结局
Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline
时间窗: The baseline values will be as follows:
次要结局
- To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile(blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite)
研究者
研究点 (4)
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