NCT00834262已完成不适用
A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients
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
- 339
- 试验地点
- 1
- 主要终点
- Number of all hypoglycaemic episodes
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 profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.
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
- •Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible
排除标准
- •Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
A
干预措施: biphasic insulin aspart 50 (Drug)
A
干预措施: biphasic insulin aspart 70 (Drug)
结局指标
主要结局
Number of all hypoglycaemic episodes
时间窗: during 13 weeks of treatment
次要结局
- Number of adverse drug reactions(during 13 weeks of treatment)
- Number of all major hypoglycaemic (daytime and nocturnal) episodes(during 13 weeks of treatment)
- Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes(during 13 weeks of treatment)
- Weight (BMI) change(at the end of the study after 13 weeks of treatment)
- Percentage of patients reaching the target of HbA1c of 7.0% or less(at the end of the study after 13 weeks of treatment)
- Number of adverse events(during 13 weeks of treatment)
- Number of major hypoglycaemic episodes related to omission of a meal after injection(during 13 weeks of treatment)
- HbA1c change(at the end of the study after 13 weeks of treatment)
- Variability in fasting blood glucose values and average (mean) fasting blood glucose level(at the end of the study after 13 weeks of treatment)
- Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration(during 13 weeks of treatment)
- Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level(at the end of the study after 13 weeks of treatment)
研究者
研究点 (1)
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