NCT01006057已完成1 期
A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects 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
- 32
- 试验地点
- 1
- 主要终点
- Area under the insulin degludec concentration-time curve
研究概览
简要总结
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
- •Body mass index maximum 40.0 kg/m^2
排除标准
- •Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Significant history of alcoholism or drug/chemical abuse
- •Not able or willing to refrain from smoking during the inpatient period
研究组 & 干预措施
ESRD
Experimental
干预措施: insulin degludec (Drug)
Mild
Experimental
干预措施: insulin degludec (Drug)
Moderate
Experimental
干预措施: insulin degludec (Drug)
Normal
Experimental
干预措施: insulin degludec (Drug)
Severe
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the insulin degludec concentration-time curve
时间窗: from 0 to 120 hours after trial product administration
次要结局
- Maximum observed insulin degludec concentration(from 0 to 120 hours after trial product administration)
- Renal clearance of insulin degludec after single-dose(from 0 to 24 hours after trial product administration)
研究者
研究点 (1)
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