NCT00869908已完成不适用
The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study
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
- 66,726
- 试验地点
- 1
- 主要终点
- Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions
研究概览
简要总结
This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
- •The selection of the subjects will be at the discretion of the individual physician.
排除标准
- •Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
- •Subjects who were previously enrolled in this study.
- •Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.
研究组 & 干预措施
A
干预措施: insulin aspart (Drug)
A
干预措施: insulin detemir (Drug)
A
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions
时间窗: at baseline, 12 weeks and 24 weeks
次要结局
- Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice(at baseline, 12 weeks and 24 weeks)
- Change in number of hypoglycaemic events(at baseline, 12 weeks and 24 weeks)
- Change in HbA1c(at baseline, 12 weeks and 24 weeks)
- Change in FPG (Fasting Plasma Glucose)(at baseline, 12 weeks and 24 weeks)
- Change in PPG (postprandial glucose)(at baseline, 12 weeks and 24 weeks)
研究者
研究点 (1)
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