NCT01467375已完成3 期
An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.
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
- •Subjects must have been correctly included in and completed BIAsp-1234
排除标准
- •Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
- •Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-
- •Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
- •Known or suspected allergy to trial product or related products
- •Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease
研究组 & 干预措施
A
Experimental
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Occurrence of adverse events
Frequency of hypoglycaemic episodes
次要结局
- HbA1c (glycosylated haemoglobin)
研究者
研究点 (1)
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