NCT01565733已完成不适用
Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With 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
- 2,223
- 试验地点
- 1
- 主要终点
- Frequency of severe hypoglycaemic episodes
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.
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
- •Patients with type 2 diabetes
- •Treated with oral anti-diabetics and/or human insulin
排除标准
- •Persons previously included in the trial
- •Hypersensitive to biphasic insulin aspart or any of the excipients
- •Pregnant or lactating women, or those who plan to get pregnant within the next 12 months
研究组 & 干预措施
NovoMix® 30 users
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Frequency of severe hypoglycaemic episodes
次要结局
- Number of severe hypoglycaemic episodes
- Average plasma glucose level at bedtime and at night
- Postprandial glucose concentration after breakfast, lunch, and dinner
- Average fasting glucose concentration after waking and before main meals
- Number of mild hypoglycaemic episodes
研究者
研究点 (1)
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