NCT00700830已完成不适用
Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With 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
- 1,976
- 主要终点
- Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
研究概览
简要总结
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Informed consent obtained before any trial-related activities
- •Type 2 diabetes
- •HbA1c between 7-9%
- •Insulin naive
- •Inadequate control with oral antidiabetics therapy as judged by investigator
排除标准
- •Patients with type 1 diabetes
- •Hypersensitivity to Levemir® or to any of the excipients
- •Pregnancy, or desire of pregnancy within next 6 months
- •HbA1c greater than or equal to 9%
- •Known or suspected allergy to the trial product or to any of the excipients
- •Subjects who are unlikely to comply with protocol
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
时间窗: During study
次要结局
- FBG (Fasting Blood Glucose)(Monthly average for each month, and average of the past quarter)
- Weight(after 12 weeks (3 months) AND after 24 weeks (6 months))
- HbA1c(after 12 weeks (3 months) AND after 24 weeks (6 months))
研究者
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