NCT00696163已完成不适用
A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects 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
- 24,975
- 试验地点
- 1
- 主要终点
- Change in Quality of Life from baseline (using QoLD questionnaire)
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.
排除标准
- •Currently treated with NovoMix® 30
- •Subjects who are unlikely to comply with protocol requirements
- •Previously enrolled in this study
- •Hypersensitivity to biphasic insulin aspart 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
Change in Quality of Life from baseline (using QoLD questionnaire)
时间窗: From baseline to 26 weeks of treatment
次要结局
- Efficacy(After 26 weeks)
- Safety(After 26 weeks)
研究者
研究点 (1)
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