NCT00383877已完成3 期
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •HbA1C greater than 7.5% and less than or equal to 11.0%
- •Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
排除标准
- •Previous acute treatment with insulin for more than 7 days.
- •Treatment with OAD(s) which does not adhere to the approval labeling.
- •Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
结局指标
主要结局
HbA1c
时间窗: after 20 weeks of treatment
次要结局
- FBG(after 20 weeks of treatment)
- Safety profile(during 20 weeks treatment)
- Proportion of subjects achieving HbA1c less than or equal to 7.0%(after 20 weeks of treatment)
- Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial(before breakfast during the trial at the end of the trial)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00592527Novo Nordisk A/S132
终止
4 期
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00506662Novo Nordisk A/S86
已完成
4 期
The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OADDiabetesDiabetes Mellitus, Type 2NCT00521690Novo Nordisk A/S25
已完成
4 期
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00807092Novo Nordisk A/S145
已完成
3 期
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00789191Novo Nordisk A/S222