临床试验/NCT00700648

NCT00700648已完成不适用

A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 3,024 人开始时间: 2008年3月最近更新: 2017年1月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 3,024
试验地点: 1
主要终点: Incidence of SAEs (serious adverse event)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.

排除标准

•Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude;
•Subjects with a hypersensitivity to NovoRapid or to any of the excipients.
•Subjects with conditions considered as contraindications.

研究组 & 干预措施

A

干预措施: insulin aspart (Drug)

结局指标

主要结局

Incidence of SAEs (serious adverse event)

时间窗: After 6 months

Incidence of AEs (adverse event)

时间窗: After 6 months

次要结局

Other safety & efficacy measures(After 6 months)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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