NCT00704223已完成不适用
Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus
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
- 619
- 主要终点
- number of major and minor hypoglycaemic events and adverse 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 adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c over 7%
- •No contraindication with NovoMix® 70
排除标准
- •Type 1 diabetes
- •Subjects participating in a clinical trial or another observational study
- •Subjects under previous basis-bolus insulin therapy
- •Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
研究组 & 干预措施
A
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
number of major and minor hypoglycaemic events and adverse events
时间窗: 3 months
次要结局
- HbA1c(3 months)
- PPBG(3 months)
- FBG(3 months)
研究者
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