NCT01697618已完成2 期
A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Area under the serum insulin curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 12 months
- •Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
- •BMI (body mass index) below 39 kg/m^2
- •HbA1c (glycosylated haemoglobin) below 12%
排除标准
- 未提供
研究组 & 干预措施
BIAsp 30
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 30
Experimental
干预措施: biphasic human insulin 30 (Drug)
BHI 30
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
BHI 30
Active Comparator
干预措施: biphasic human insulin 30 (Drug)
结局指标
主要结局
Area under the serum insulin curve
次要结局
- Overall shape of the 24 hour serum glucose profile
- Serum glucose excursions (EXC)
- Cmax (maximum plasma concentration)
- tmax (time to reach maximum)
- Overall shape of the 24 hour serum insulin profile
- Area under the curve following each injections derived from 24 hours serum insulin profiles
研究者
研究点 (1)
Loading locations...
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