NCT00806897已完成不适用
Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen
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
- 74
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline
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 NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Type 2 diabetic subjects on intensive insulin treatment (IIT)
- •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
Change in HbA1c from baseline
时间窗: at 24 weeks
次要结局
- Change in body weight(at 12 weeks/24weeks)
研究者
研究点 (1)
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