NCT01467401已完成4 期
A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- HbA1c (glycolated haemoglobin)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 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
- Parallel
- 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
- •Type 2 diabetes for at least 24 months
- •Insulin treatment for the pase 3 months
- •HbA1c (glycosylated haemoglobin) below 13%
- •BMI (Body Mass Index) below 40 kg/m^2
- •Ability and willingness to perform self-blood glucose monitoring
排除标准
- •Receipt of any investigational drug within 4 weeks prior to this trial
- •Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
- •Total daily insulin dosage less than or equal to 1.8 IU/kg
研究组 & 干预措施
A
Experimental
干预措施: biphasic insulin aspart (Drug)
B
Active Comparator
干预措施: biphasic human insulin (Drug)
结局指标
主要结局
HbA1c (glycolated haemoglobin)
次要结局
- Number and severity of hypoglycaemic episodes
- 7-point blood glucose profile
- Number and severity of local tolerability issues at the injection site
- Prandial increment in blood glucose
- Number and severity of adverse events
研究者
研究点 (1)
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