NCT01486875已完成不适用
NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,155
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions (SADRs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes
排除标准
- 未提供
研究组 & 干预措施
BIAsp 30
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions (SADRs)
时间窗: Week 26
Incidence of major hypoglycaemic events
时间窗: Week 26
次要结局
- Number of all hypoglycaemic events(In the 4 weeks prior to week 12 and week 26, respectively)
- HbA1c (glycosylated haemoglobin A1c)(Week 26)
- Fasting Plasma Glucose (FPG)(Week 26)
研究者
研究点 (1)
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