NCT01097681已完成1 期
An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Plasma concentration of ASP1941
研究概览
简要总结
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients for at least 12 weeks
- •Fasting plasma glucose level of < 240 mg/dL
- •Body Mass Index ( BMI )20.0 - 35.0kg/m2
- •GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
排除标准
- •Type 1 diabetes mellitus patients
- •Receiving insulin within 12 weeks before screening
- •Diabetic ketoacidosis
- •Dysuria and/or urinary tract infection, genital infection
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
研究组 & 干预措施
Normal renal function group
Experimental
oral
干预措施: ASP1941 (Drug)
Mild renal impairment group
Experimental
oral
干预措施: ASP1941 (Drug)
Moderate renal impairment group
Experimental
oral
干预措施: ASP1941 (Drug)
结局指标
主要结局
Plasma concentration of ASP1941
时间窗: For 72 hours after dosing
次要结局
- Urinary levels of ASP1941(For 72 hours after dosing)
- Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs(For 72 hours after dosing)
- Urinary glucose excretion(For 72 hours after dosing)
研究者
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