NCT00699179已完成不适用
EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice
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
- 2,308
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
- •HbA1c greater than 7%
- •Informed Consent
排除标准
- •Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- •Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
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: After 6 months
次要结局
- Change in body weight and waist circumference(at 12 weeks and 26 weeks of treatment compared to baseline)
- Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus(after 12 weeks and 26 weeks compared to baseline)
- Change in FPG (glucose variability)(after 12 weeks and 26 weeks compared to baseline)
- Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits(at 12 weeks and 26 weeks of treatment compared to baseline)
- Change in PPG (postprandial control)(after 12 weeks and 26 weeks compared to baseline)
- Change in insulin dose and number of injections(at 12 weeks and 26 weeks of treatment)
- Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study(after 12 weeks and 26 weeks of treatment compared to baseline)
- Number of adverse drug reactions (ADR)(after 12 weeks and 26 weeks of treatment)
研究者
研究点 (1)
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