NCT00318786已完成3 期
Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C (HbA1C)
研究概览
简要总结
This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes
- •Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
- •HbA1c at least 7.5% and below 10.0%
排除标准
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Impaired hepatic and/or renal function
- •Cardiac diseases
- •Uncontrolled hypertension
- •Known hypoglycemia unawareness or recurrent major hypoglycemia
结局指标
主要结局
Hemoglobin A1C (HbA1C)
时间窗: After 16 weeks of treatment
次要结局
- HbA1C, after 28 weeks of treatment; Plasma glucose levels
研究者
研究点 (2)
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