NCT00737776已完成不适用
NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
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
- 1,068
- 试验地点
- 1
- 主要终点
- HbA1c change
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.
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 patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
- •Patient who signed on informed consent form
排除标准
- •Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- •Patients who were previously enrolled in this study
- •Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 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
HbA1c change
时间窗: at the end of study after 26 weeks
次要结局
- Number of serious adverse drug reactions(during the study)
- Number of major hypoglycaemic events related to physical exercise of at least 30 min(during the study)
- Number of all minor (daytime and nocturnal) hypoglycaemic events(during the study)
- Percentage of patients reaching the target of HbA1c below or equal to 6.5%(at the end of study after 26 weeks)
- Percentage of patients reaching the physician's own target recommendation(at the end of study after 26 weeks)
- Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection(during the study)
- Weight (BMI) change(at the end of study after 26 weeks)
- Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change(at the end of study after 26 weeks)
- Percentage of patients reaching the target of HbA1c below or equal to 7.0%(at the end of study after 26 weeks)
- Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level(at the end of study after 26 weeks)
- Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level(at the end of study after 26 weeks)
- Diabetes Fear of Self-Injection Questionnaire (D-FISQ)(at the end of study after 26 weeks)
- Number of serious adverse events(during the study)
- Number of all major (daytime and nocturnal) hypoglycaemic events(during the study)
研究者
研究点 (1)
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