NCT00592527已完成3 期
Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Asia.
The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetes for at least 12 months since diagnosis
- •Insulin naive subjects
- •OAD treatment for at least 4 months with max. two OAD treatments
- •Body mass index below 30.0 kg/m2
- •HbA1c between 7.0-11.0%
排除标准
- •OAD treatment with three or more OADs
- •Secondary diabetes
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
- •Uncontrolled hypertension
- •Known or suspected allergy to trial product or related products
结局指标
主要结局
HbA1c
时间窗: after 20 weeks of treatment
次要结局
- Fasting plasma glucose (FPG)
- Within-subject variation
- Change in body weight
- Incidence of adverse events
研究者
研究点 (6)
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