NCT00709475已完成不适用
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 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
- 747
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the physician decision has been made to use 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. The selection of the subjects will be at the discretion of the individual physician
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 insulin detemir;
- •Subjects who previously enrolled in this study or studies related to NovoMix 30;
- •Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events
时间窗: For the duration of the study (32 weeks)
次要结局
- Number of serious adverse events(For the duration of the study)
- Fasting glucose level control compared to baseline as measured by FBG(After 16 and 32 weeks of treatment)
- Weight changes compared to baseline(At the end of the study)
- HbA1c compared to baseline(At the end of the study)
- Number of all adverse events(For the duration of the study)
- Number of all - daytime and nocturnal - hypoglycaemic events(In the 4 weeks before baseline compared to 4 weeks before interim and final visits)
研究者
研究点 (1)
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