NCT00842192已完成不适用
A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries
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
- 2,155
- 试验地点
- 1
- 主要终点
- Change in number of hypoglycaemic events from baseline
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label
排除标准
- •Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
- •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 6 months. Women of childbearing potential who are not using adequate contraceptive methods
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Change in number of hypoglycaemic events from baseline
时间窗: at 12 and 24 weeks
HbA1c
时间窗: at 12 and 24 weeks
次要结局
- Glucose variability as measured by FPG(at 12 and 24 weeks)
- Number of adverse drug reactions (ADR)(at 12 and 24 weeks)
- Postprandial glycaemic control as measured by PPG(at 12 and 24 weeks)
- Insulin dose and number of injections(at 12 and 24 weeks)
- Body weight(at 12 and 24 weeks)
- Percentage of subjects to reach HbA1c between 6.5 and 7.0%(at 12 and 24 weeks)
研究者
研究点 (1)
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