NCT00775736已完成不适用
Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)
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
- 611
- 试验地点
- 1
- 主要终点
- The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.
研究概览
简要总结
This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice
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
- •Type 2 diabetes mellitus
排除标准
- •Known or suspected allergy to study product or related products.
- •Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 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
The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.
时间窗: At baseline, 12 and 26 weeks.
次要结局
- Number of all hypoglycaemic episodes.(At baseline, 12 and 26 weeks.)
- HbA1c(at 12 and 26 weeks)
- Weight changes(at 12 and 26 weeks)
- Number of all adverse drug reactions.(At baseline, 12 and 26 weeks.)
- Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels(at 12 and 26 weeks)
研究者
研究点 (1)
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