NCT01520753已完成3 期
A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Fasting serum glucose
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 diabetes for longer than 12 months
- •Body mass index (BMI) below 35.0 kg/m^2
- •HbA1c below 11.0 %
- •Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
排除标准
- •Current treatment with agents affecting glucose metabolism
- •History of drug or alcohol dependence
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac disease
- •Proliferative retinopathy
- •Recurrent severe hypoglycaemia or advanced neuropathy
研究组 & 干预措施
BIAsp 70 + BIAsp 50
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 70
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 70 + BIAsp 50
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
结局指标
主要结局
Fasting serum glucose
次要结局
- 24-hour serum glucose profiles
- Incidence of hypoglycaemic episodes
- 24-hour insulin profiles
- Incidence of adverse events
研究者
研究点 (1)
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