NCT00605111已完成4 期
Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 18
- 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 investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.
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 for at least 24 months
- •BMI between 18 and 30 kg/m2
- •Insulin naive subjects
- •OAD treatment with max two OADs alone or combined with other therapy
- •HbA1c between 7-12%
排除标准
- •Type 1 diabetes
- •Receipt of any investigational drug within the last three months prior to this trial
- •Current or previous treatment with thiazolidiones within the last 6 months
- •OAD treatment with three or more OADs within the last 4 months
结局指标
主要结局
HbA1c
时间窗: after 11 weeks of treatment
次要结局
- The proportion of subjects achieving treatment target of HbA1c below 7%(at 11 and 24 weeks)
- 8-point plasma glucose profiles(performed at 11 and 24 weeks)
- FPG(at 11 weeks and 24 weeks)
研究者
研究点 (18)
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