NCT00659282已完成不适用
Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of 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
- 57,610
- 试验地点
- 1
- 主要终点
- Incidence of major hypoglycaemic events reported as serious adverse drug reactions
研究概览
简要总结
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age according to approved label and physician discretion
- •Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before
排除标准
- •Subjects who previously enrolled in this study
- •Subjects who are unlikely to comply with protocol requirements
- •Hypersensitivity to biphasic insulin aspart or to any of the excipients
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
研究组 & 干预措施
A
biphasic insulin aspart
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
时间窗: during treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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