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临床试验/NCT00657930
NCT00657930已完成不适用

Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)

Novo Nordisk A/S0 个研究点目标入组 2,289 人开始时间: 2008年3月最近更新:
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
2,289
主要终点
Efficacy (HbA1c)

研究概览

简要总结

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetic subjects on intensive insulin treatment (ICT)
  • Eligibility for once daily insulin detemir administration
  • Informed consent obtained before any observation-related activities

排除标准

  • Known or suspected allergy to insulin detemir
  • Subjects previously enrolled in the observation
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.

研究组 & 干预措施

A

干预措施: insulin detemir (Drug)

结局指标

主要结局

Efficacy (HbA1c)

时间窗: 24 weeks

次要结局

  • Hypoglycaemia frequency(24 weeks)
  • FBG variability(24 weeks)
  • Insulin dose change(24 weeks)
  • Body weight(24 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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