NCT00698126已完成不适用
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study
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
- 4,099
- 试验地点
- 1
- 主要终点
- Number of major hypoglycaemic events reported as serious adverse drug reactions
研究概览
简要总结
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes
- •Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years
排除标准
- •Patients with an end-stage renal failure
- •Patients with a serious liver disease
- •Patients with concomitant malignant disease
研究组 & 干预措施
A
干预措施: soluble human insulin (Drug)
B
干预措施: biphasic insulin aspart (Drug)
结局指标
主要结局
Number of major hypoglycaemic events reported as serious adverse drug reactions
时间窗: after 26 weeks
次要结局
- Number of major hypoglycaemic events related to omission of a meal after injection(during 26 weeks)
- Number of serious and non serious drug reactions(during 26 weeks)
- Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level(after 26 weeks)
- Number of all major (daytime and nocturnal) hypoglycaemic events(during 26 weeks)
- Number of major hypoglycaemic events related to physical exercise of at least 30 min duration(during 26 weeks)
- Number of serious adverse event(during 26 weeks)
- Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit(after 26 weeks)
- Weight and waist circumference change(during 26 weeks)
- Quality of Life (QoL)(after 26 weeks)
研究者
研究点 (1)
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