NCT00696995已完成不适用
An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- The number of serious adverse drug reactions, including major hypoglycaemic events
研究概览
简要总结
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes
- •Insulin-naive or previously treated by basal only insulin therapy
排除标准
- •Patients who are unlikely to comply with the protocol
- •Pregnancy or breastfeeding or intention of becoming pregnant
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
The number of serious adverse drug reactions, including major hypoglycaemic events
时间窗: at 26 weeks
次要结局
- HbA1c(at 12 weeks and 26 weeks)
- The number of all hypoglycaemic events(at 26 weeks)
- Fasting plasma glucose at visits(at 12 weeks and 26 weeks)
研究者
研究点 (1)
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