NCT00184574已完成3 期
Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 603
- 试验地点
- 109
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Currently treated with insulin
- •Currently treated with Metformin
- •HbA1c: 7.5-12.0%
排除标准
- •Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
- •Metformin contraindications according to local practice
- •TZDs within 6 months prior to randomisation
结局指标
主要结局
HbA1c
时间窗: after 36 weeks
次要结局
- 8-point plasma glucose profiles
- Safety variables
- Other glycemic variables
研究者
研究点 (109)
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