NCT01269606已完成1 期
A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus
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
- 13
- 主要终点
- Clearance at steady state (CLss) for IV treatment group
研究概览
简要总结
This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Treated with multiple daily insulin injections for at least 12 months
- •Current daily basal insulin requirement above or equal to 0.3 U/kg/day
- •Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
- •Body Mass Index (BMI) 18.0-28.0 kg/m^2
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
- •Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
- •Subject who smokes more than 10 cigarettes or the equivalent per day
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
Treatment sequence 1 - IM treatment group
Experimental
干预措施: insulin aspart (Drug)
Treatment sequence 2 - IM treatment group
Experimental
干预措施: insulin human (Drug)
Treatment sequence 1 - IV treatment group
Experimental
干预措施: insulin aspart (Drug)
Treatment sequence 2 - IV treatment group
Experimental
干预措施: insulin human (Drug)
结局指标
主要结局
Clearance at steady state (CLss) for IV treatment group
时间窗: from 180 min to 240 min
Area under the curve (AUC) for IM treatment group
时间窗: from 0 to 480 min after intramuscular injection
次要结局
- Area under the curve (AUC) for IM treatment group(from 0 minutes to infinite time after intramuscular injection)
- Steady state concentration (Css) for IV treatment group(from 180 min to 240 min)
- Hypoglycaemic episodes(from screening (visit 1) to follow-up visit (2-21 days after last trial product administration))
- Adverse Events (AEs)(from first trial related activity to follow-up visit (2-21 days after last trial product administration))
研究者
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