NCT01524809已完成1 期
A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
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
- 26
- 试验地点
- 1
- 主要终点
- Area under the serum insulin curve 6-14 hours after dinner at day 15
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
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
- Double (Participant, Investigator)
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
- •Type 1 diabetes for at least 12 months
- •Currently on a multiple dose insulin regimen
- •HbA1c maximum 12.0%
- •BMI (body mass index) below 35 kg/m^2
- •Able and willing to perform self-blood glucose monitoring (SBGM)
排除标准
- •Treatment with insulin aspart within the last 14 days prior to this trial
- •The receipt of any investigational drug within the last 30 days prior to this trial
- •Total daily insulin dose at least 1.8 U/kg
- •A history of drug abuse or alcohol dependence within the last 5 years
- •Impaired hepatic function
- •Impaired renal function
- •Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
- •Cardiac disease
- •Severe, uncontrolled hypertension
研究组 & 干预措施
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Treatment period 2
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Treatment period 2
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
结局指标
主要结局
Area under the serum insulin curve 6-14 hours after dinner at day 15
次要结局
- Area under the curve 0-24 hours
- Serum insulin
- Apparent t½ (apparent elimination half life)
- Cmax, maximum concentration
- tmax, time to reach Cmax
- Area under the serum insulin curve 6-14 hours after dinner at day 1
- Adverse events
- Area under the serum insulin curve 0-6 hours after dinner
研究者
研究点 (1)
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