NCT01497561已完成1 期
A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 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
- 15
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Subjects treated with insulin for minimum 3 months
- •Duration of diabetes for at least 12 months
- •Body Mass Index (BMI) below 30 kg/m^2
- •HbA1c maximum 10% based on analysis from central laboratory
排除标准
- •Current treatment with insulin above 1.2 U/kg/day
- •Current treatment with insulin glargine
- •Current treatment with drugs known to interfere with glucose metabolism
- •Current treatment with oral antidiabetic drugs
研究组 & 干预措施
insulin detemir
Experimental
干预措施: insulin detemir (Drug)
insulin NPH
Active Comparator
干预措施: insulin NPH (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
次要结局
- Area under the curve
- Maximum glucose infusion rate
- Maximum concentration
- Time to maximum concentration
- Insulin clearance
- Mean residence time of insulin
- Terminal rate constant
- Terminal half-life
- Time to maximum glucose
研究者
研究点 (1)
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