临床试验/NCT01180530

NCT01180530已完成不适用

A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 358 人开始时间: 2010年10月最近更新: 2017年2月8日

适应症

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: 358
试验地点: 1
主要终点: The incidence of technical complaints related to adverse reactions

研究概览研究设计入排标准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, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.

研究设计

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

入排标准

年龄范围: 2 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Children/adolescents with type 1 diabetes mellitus
•After the participating physician's decision has been made to initiate treatment with NovoPen Echo®, any patient who meets all the inclusion criteria and does not meet any of the exclusion criteria, is eligible to participate
•Use of insulin pen or syringes for at least 12 months

排除标准

•Insulin pump or Insuflon® users
•Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion

结局指标

主要结局

The incidence of technical complaints related to adverse reactions

时间窗: after 12-18 weeks (end of study)

次要结局

未报告次要终点

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

不适用

Observational Study to Evaluate the Safety of Levemir® in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00825643Novo Nordisk A/S18,481

已完成

不适用

Observational Study to Evaluate the Safety of Levemir® in DiabetesDiabetesDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1

NCT00659295Novo Nordisk A/S51,170

已完成

不适用

A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in JapanCongenital Bleeding DisorderGlanzmann's Disease

NCT01876745Novo Nordisk A/S4

已完成

不适用

Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or BCongenital Bleeding DisorderHaemophilia AHaemophilia B

NCT01220141Novo Nordisk A/S51

已完成

2 期

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With InhibitorsCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

NCT00951405Novo Nordisk A/S23