A Study Evaluating the Safety of NovoPen®3 and FlexPen® in Subjects With Type 1 and Type 2 Diabetes. A 24-week, Prospective, Multi-centre, Open-labelled, Non-interventional Study

Novo Nordisk A/S0 个研究点目标入组 1,031 人开始时间: 2011年11月最近更新: 2015年6月12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: 1,031
主要终点: Number of adverse events and technical complaints

研究概览研究设计入排标准结局指标研究者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 of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.

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

•Any subjects who are previously using Actrapid®, Insulatard®, and Mixtard® 30 with vial / NovoLet® or insulin human with ErgoPen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices

排除标准

•Subjects treated with Actrapid® Penfill®, Insulatard® Penfill®, or Mixtard® 30 Penfill® with NovoPen®3 or Actrapid® FlexPen®, Insulatard® FlexPen®, or Mixtard® 30 FlexPen® for more than 4 weeks before inclusion into this study
•Subjects who were previously enrolled in this study
•Subjects with a hypersensitivity to insulin human or to any of the excipients
•Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months

结局指标

主要结局

Number of adverse events and technical complaints

时间窗: Week 0-24

次要结局

HbA1c (haemoglobin A1c)(Week 0, week 12 and week 24)
Number of adverse drug reactions (ADR) including hypoglycaemic events(Week 0-12, week 24)
Number of serious adverse drug reactions including major hypoglycaemic events(Week 0-12, week 24)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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