NCT00521690已完成4 期
Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events, including major hypoglycaemic events
研究概览
简要总结
The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1C: 7.0-11.0%
- •Previous diabetes treatment for at least 6 months
- •BMI max. 35 kg/m2
- •Treatment with an oral anti-diabetic drug (OAD)
排除标准
- •Type 1 diabetes
- •Receipt of any investigational drug within the last three months prior to this trial
结局指标
主要结局
Incidence of serious adverse events, including major hypoglycaemic events
时间窗: during 16 weeks of insulin detemir therapy
次要结局
- Change in HbA1C(after 16 weeks)
- Change in weight
- Incidence of hypoglycaemic episodes
- Change in fasting plasma glucose (FPG)
研究者
研究点 (1)
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