NCT01704378已完成4 期
A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
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
- 89
- 试验地点
- 1
- 主要终点
- Number of Hypoglycaemic episodes
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial investigate the the long-term 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
- Non Randomized
- 干预模型
- Single Group
- 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
- •Signed informed consent obtained before any trial-related activities
- •Completed the trial BIAsp-1236
排除标准
- •Planned changes in use of any prescription medication that may interfere with glucose regulation
- •Known or suspected allergy to trial products or related products
- •Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
- •Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
研究组 & 干预措施
BIAsp
Experimental
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Number of Hypoglycaemic episodes
Occurrence of adverse events
次要结局
- HbA1c (glycosylated haemoglobin)
- Prandial increment in blood glucose
- 7-point blood glucose profile
研究者
研究点 (1)
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