NCT00771680已完成不适用
Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.
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
- 10,408
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator
排除标准
- •In accordance with approved label
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
A
干预措施: biphasic insulin aspart 30 (Drug)
A
干预措施: insulin aspart (Drug)
结局指标
主要结局
HbA1c
时间窗: at baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic events
时间窗: during 12 months of treatment
次要结局
- Number of all minor (daytime and nocturnal) hypoglycaemic events(During 4 weeks prior to each study visit)
- Number of serious adverse drug reactions(during 12 months of treatment)
- Number of all major (daytime and nocturnal) hypoglycaemic events(during 12 months of treatment)
- Weight (BMI) change(At 6 and 12 months)
- Variability in fasting blood glucose values and average (mean) fasting blood glucose level(At baseline visit and after 6 and 12 months treatment)
- Average post-prandial blood glucose level (2h after dinner)(At baseline visit and after 6 and 12 months treatment)
- Quality of Life (QoL) as assessed by patient questionnaire(At baseline and the end of 6 and 12 months treatment)
研究者
研究点 (1)
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