NCT00701155已完成不适用
Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or 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
- 3,593
- 主要终点
- Incidence of serious ADRs incl. major hypoglycemias
研究概览
简要总结
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（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, any subject with Type 1 or Type 2 diabetes mellitus 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
- •Subjects with a hypersensitivity to insulin detemir or to any of the excipients
- •Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)
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 ADRs incl. major hypoglycemias
时间窗: after 24 weeks
次要结局
- Weight changes(after 24 weeks)
- Number of serious adverse events(after 24 weeks)
- Number of all adverse events(after 24 weeks)
- HbA1c(after 24 weeks)
- Subgroup analysis of hypoglycemias(after 24 weeks)
- Number of all hypoglycemic events(in the 4 weeks preceding the visits at 12 weeks and 24 weeks.)
- Variability in fasting Blood Sugar and average plasma glucose levels(after 24 weeks)
研究者
相似试验
已完成
不适用
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®DiabetesDiabetes Mellitus, Type 2NCT00709683Novo Nordisk A/S216
已完成
不适用
Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 DiabetesDiabetes Mellitus, Type 1DiabetesDiabetes Mellitus, Type 2NCT00700765Novo Nordisk A/S1,531
已完成
不适用
Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic AgentsDiabetesDiabetes Mellitus, Type 2NCT00715780Novo Nordisk A/S1,667
已完成
不适用
Evaluation of Levemir® for the Treatment of Type 1 and 2 DiabetesDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT00655044Novo Nordisk A/S3,637
已完成
不适用
Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00704223Novo Nordisk A/S619