NCT00280046已完成3 期
Effect of Biphasic Insulin Aspart 30 on Glycaemic 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
- 307
- 试验地点
- 11
- 主要终点
- HbA1c
研究概览
简要总结
This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
- •HbA1c: At least 8.0%
排除标准
- •Impaired hepatic, renal or cardiac function
结局指标
主要结局
HbA1c
时间窗: after 16 weeks of treatment
次要结局
- Self-measured 7-point capillary plasma glucose profile
- Change in body weight
- Incidence of hypoglycaemic episodes and adverse events
- Quality of Life
研究者
研究点 (11)
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