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临床试验/NCT00793273
NCT00793273已完成不适用

Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

Novo Nordisk A/S0 个研究点目标入组 1,074 人开始时间: 2008年11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
1,074
主要终点
Change in FPG (fasting plasma glucose) of treatment

研究概览

简要总结

This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients with type 2 diabetes mellitus
  • Insulin-naive or currently treated with another basal insulin
  • Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

排除标准

  • Type 1 diabetes mellitus
  • Patients treated with short acting or with premix insulin
  • Women who are pregnant, breast feeding or have the intention to become pregnant
  • Known or suspected allergy to the study product or related product
  • Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)

研究组 & 干预措施

A

干预措施: insulin detemir (Drug)

结局指标

主要结局

Change in FPG (fasting plasma glucose) of treatment

时间窗: after 12 to 16 weeks

Change in HbA1c of treatment

时间窗: after 12 to 16 weeks

次要结局

  • Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation(after 12 to 16 weeks)
  • Occurrence of adverse events(after 12 to 16 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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