NCT00842894已完成不适用
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,421
- 主要终点
- Incidence of serious adverse drug reactions (SADRs)
研究概览
简要总结
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.
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
- •After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label
排除标准
- •Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- •Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
- •Subjects who were previously enrolled in this study
- •Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
研究组 & 干预措施
Insulin detemir
干预措施: insulin detemir (Drug)
Biphasic insulin aspart 30
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions (SADRs)
时间窗: after 26 weeks
次要结局
- Number of all minor hypoglycaemic events(during 4 weeks preceding each visit)
- Number of all major hypoglycaemic events(during 13 weeks preceding each visit)
- HbA1c(after 26 weeks)
- Percentage of subjects to reach HbA1c below 7.0%(after 13 weeks and 26 weeks)
- The effect on glycaemic control as measured by FPG (fasting plasma glucose)(after 13 weeks and 26 weeks)
- The effect on glycamic control as measured by PG profile(after 13 weeks and 26 weeks)
- Change in body weight(after 13 weeks and 26 weeks)
研究者
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