NCT00605020已完成3 期
Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in 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
- 719
- 试验地点
- 128
- 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 and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Duration of type 2 diabetes for at least 6 months since diagnosis
- •Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
- •BMI below 40 kg/m2
- •HbA1c between 7-12%
- •Able and willing to perform self-monitoring of capillary blood glucose
排除标准
- •Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
- •Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- •Known or suspected allergy to trial product or related products
- •Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
- •Receipt of any investigational drug within 4 weeks prior to this trial
- •Previous participation in this trial
结局指标
主要结局
HbA1c
时间窗: after 6 months of treatment
次要结局
- Incidence of hypoglycaemic episodes
- Adverse events
- Difference of HbA1c change between the two groups(after 13 weeks of treatment)
- Fasting plasma glucose of treatment(after 13 and 26 weeks)
- Change in weight
研究者
研究点 (128)
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