NCT01526980已完成2 期
A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
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
- 31
- 试验地点
- 1
- 主要终点
- Glucose average in 24-hour blood glucose profiles
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 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
- None
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
- •Subjects with Type 2 diabetes
- •Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
- •HbA1c maximum 10.0%
- •BMI (Body Mass Index) maximum 35.0 kg/m2
- •Able and willing to perform self-blood glucose monitoring (SBGM)
排除标准
- •The receipt of any investigational drug within the last 30 days prior to this trial
- •Total daily insulin dose minimum 2.0 U/(kg·day)
- •A history of drug abuse or alcohol dependence within the last 5 years
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac disease
- •Severe, uncontrolled hypertension
研究组 & 干预措施
Treatment period 2
Active Comparator
干预措施: biphasic insulin aspart 70 (Drug)
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 1
Experimental
干预措施: biphasic human insulin 30 (Drug)
Treatment period 2
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
Treatment period 2
Active Comparator
干预措施: biphasic human insulin 30 (Drug)
结局指标
主要结局
Glucose average in 24-hour blood glucose profiles
次要结局
- tmax, time of maximum concentration of total insulin
- The area under the 24-hour total insulin concentration time curve
- Post-meal excursion of glucose (0-4 hours)
- Pre-meal glucose level
- Adverse events
- Cmax, maximum concentration of total insulin
研究者
研究点 (1)
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