NCT00698269已完成不适用
Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 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
- 5,926
- 试验地点
- 1
- 主要终点
- Incidence of major hypoglycaemic events reported
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes
- •Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
- •Selection will be at the discretion of the individual physician
排除标准
- •Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
- •Previous enrolled in this study
- •Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
- •Women who are pregnant, breast feeding 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)
B
干预措施: biphasic insulin aspart 30 (Drug)
C
干预措施: insulin aspart (Drug)
结局指标
主要结局
Incidence of major hypoglycaemic events reported
时间窗: during 24 weeks of treatment
Change in HbA1c
时间窗: during 24 weeks of treatment
次要结局
- Change in PPG(at 12 & 24 weeks)
- Body weight(at 12 & 24 weeks)
- Change in number of hypoglycaemic events in the last 4 weeks before routine visits(at 12 & 24 weeks)
- Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits(at 12 & 24 weeks)
- Percentage of subjects achieving HbA1c below 7.0%(at 12 & 24 weeks)
- Change in FPG(at 12 & 24 weeks)
- Number of adverse drug reactions (ADR)(at 12 & 24 weeks)
研究者
研究点 (1)
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