NCT00729898已完成不适用
Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes
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
- 243
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions, including major hypoglycaemic events
研究概览
简要总结
This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.
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 diabetes type 2 diabetes
- •Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
- •Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient
排除标准
- •Known or suspected allergy to study product(s) or related products
- •Pregnancy, breast-feeding 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)
结局指标
主要结局
Incidence of serious adverse drug reactions, including major hypoglycaemic events
时间窗: after 12 and 26 weeks
次要结局
- Variability in fasting plasma glucose (FPG) values and average FPG levels(at visits at 12 and 26 weeks)
- Weight changes(at visits at 12 and 26 weeks)
- HbA1c(at 12 and 26 weeks)
- Number of all hypoglycaemic events(in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks)
- Number of all adverse drug reactions(after 12 and 26 weeks)
研究者
研究点 (1)
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