NCT00671008已完成不适用
Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus
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
- 400
- 主要终点
- Glycaemic control as measured by HbA1c
研究概览
简要总结
This trial is conducted in Europe.
The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 1 or Type 2 diabetes, including newly diagnosed
- •Age: Levemir® above 6 years
- •Age: Novomix® above 18 years
排除标准
- •Current treatment with NovoMix® 30 or Levemir®
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
B
干预措施: insulin detemir (Drug)
结局指标
主要结局
Glycaemic control as measured by HbA1c
时间窗: After 24 weeks
次要结局
- Percentage of subjects to reach HbA1c below 7.0% and =6.5%(After 24 weeks)
- Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30(After 24 weeks)
- The effect on glycamic control as measured by FPG(After 24 weeks)
- The effect on glycamic control as measured by PG profile(After 24 weeks)
- Change in body weight(After 24 weeks)
研究者
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