NCT00455858已完成4 期
A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 主要终点
- Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
研究概览
简要总结
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
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 (diagnosed more than 12 months ago)
- •HbA1c greater than 7.0 and less than 12.0% at screening
- •Currently on any OAD in more than 3 months ago
- •BMI (Body Mass Index) less than 35kg/m2
排除标准
- •Previous treatment with insulin in more than 7 days within the last 3 months
- •Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
研究组 & 干预措施
insulin detemir
Active Comparator
干预措施: insulin detemir (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
时间窗: week 0, week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20
次要结局
- Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12(week 0, week 12)
- Occurence of Hypoglycaemic Episodes(weeks 0-20)
- Change in Fasting Plasma Glucose (FPG)(week 0, week 12, week 20)
- Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%(week 12, week 20)
研究者
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