NCT00600366已完成4 期
Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Insulin naive diabetes
- •Current treatment with OHA, secondary failure
- •Body mass index (BMI) below 40 kg/m2
- •HbA1c over 8.5%
- •Willing and able to start with insulin therapy and to perform self-blood glucose monitoring
排除标准
- •History of drug or alcohol abuse
- •Receipt of the investigational drug within the last month prior to this trial
- •Known or suspected allergy to trial products or related products
- •Severe uncontrolled hypertension
- •Any disease or condition, which the Investigator feels, would interfere with the trial
结局指标
主要结局
HbA1c
时间窗: after 12 weeks of treatment
次要结局
- Blood glucose profiles
- Incidence of hypoglycaemic episodes
- Incidence of adverse events
研究者
研究点 (5)
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