NCT01526941已完成1 期
A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics 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
- 27
- 试验地点
- 1
- 主要终点
- Steady state area under the glucose infusion rate profile, 6-12 hours
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics 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 basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
- •BMI (Body Mass Index) maximum 35 kg/m^2
- •Able and willing to perform self-blood glucose monitoring
排除标准
- •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/day
- •Currently being treated with insulin aspart products
- •A history of drug abuse or alcohol dependence within the last 5 years
- •Impaired hepatic function
- •Impaired renal function
- •Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
- •Cardiac problems
- •Severe, uncontrolled hypertension
研究组 & 干预措施
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 30 (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
Steady state area under the glucose infusion rate profile, 6-12 hours
次要结局
- Time to 50% of area under the glucose infusion rate profile, 0-12 hours
- tmax, time to reach Cmax
- Adverse events
- GIRmax, the maximal glucose infusion rate value
- area under the glucose infusion rate profile
- Cmax, maximum concentration
- Area under the curve
- tmax, time to maximum glucose infusion rate value
- t½, terminal half-life
研究者
研究点 (1)
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