跳至主要内容
临床试验/NCT00687284
NCT00687284已完成不适用

Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 2,188 人开始时间: 2008年2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
2,188
试验地点
1
主要终点
Change in glycaemic control as measured by HbA1c.

研究概览

简要总结

This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with type 2 diabetes
  • Patients inadequately controlled by OAD
  • Patients willing to sign informed consent
  • Selection of study participants at the discretion of the physician
  • Particular attention should be paid to the drug interactions that are listed within the product label

排除标准

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 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

Change in glycaemic control as measured by HbA1c.

时间窗: For the duration of the study

次要结局

  • The effect on glycaemic control as measured by FPG(After 12 weeks and 24 weeks)
  • Change in body weight(After 12 weeks and 24 weeks)
  • Change in waist and hip perimeter(After 12 weeks and 24 weeks)
  • Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%(After 12 weeks and 24 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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