NCT00675493已完成不适用
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania
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
- 942
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).
排除标准
- •Subjects currently being treated with biphasic insulin aspart 30
- •Subjects who were previously enrolled in this study
- •Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- •Women who are pregnant or have the intention of becoming pregnant within next 6 months
- •Children below 10 years of age
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: For the duration of the study
次要结局
- Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%(after 12 weeks and 24 weeks of treatment)
- Change in FPG (glucose variability)(after 12 weeks and 24 weeks of treatment)
- Change in PPG (postprandial control)(after 12 weeks and 24 weeks of treatment)
- Change in insulin dose and number of injections(at 12 weeks and 24 weeks of treatment)
- Change in oral antidiabetic drug therapy(after 12 weeks and 24 weeks of treatment)
- Change in body weight(at 12 weeks and 24 weeks of treatment)
- Change in number of hypoglycaemic events(during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment)
- Number of adverse drug reactions (ADR)(after 12 weeks and 24 weeks of treatment)
研究者
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