A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 12 months
- •Serum C-peptide maximum 0.4 ng/mL
- •Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
- •BMI (Body Mass Index) maximum 32 kg/m^2
- •HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
- •Non-smoker
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
- •Current treatment with IAsp (insulin aspart) products
- •A history of drug or alcohol abuse within the last 5 years
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Severe, uncontrolled hypertension
研究组 & 干预措施
BIAsp 30
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 30
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 50
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 30
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 30
干预措施: insulin aspart (Drug)
BIAsp 50
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 50
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 50
干预措施: insulin aspart (Drug)
BIAsp 70
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 70
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 70
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 70
干预措施: insulin aspart (Drug)
IAsp
干预措施: biphasic insulin aspart 30 (Drug)
IAsp
干预措施: biphasic insulin aspart 50 (Drug)
IAsp
干预措施: biphasic insulin aspart 70 (Drug)
IAsp
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
次要结局
- Hypoglycaemic episodes
- Maximum GIR value
- Maximum drug concentration for insulin aspart (IAsp)
- Time to maximum IAsp concentration
- Area under the GIR-curves
- Area under the curve of the IAsp profiles
- Minimum drug concentration in NEFA (Nonesterified fatty acids)
- Time to minimum plasma concentration, NEFA
- Area under the curve of the NEFA profiles
- Adverse events
- Time to maximum GIR value