NCT01467323已完成3 期
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
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
- 303
- 试验地点
- 1
- 主要终点
- HbA1c (glycosylated haemoglobin A1c)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or 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
- •Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
- •Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
- •Body mass index (BMI) below or equal to 35.0 kg/m^2
- •HbA1c below or equal to 11.0%
排除标准
- •Total daily insulin dose at least 1.4 IU/kg
- •Treatment with oral hypoglycaemic agents within the month prior to inclusion
- •Recurrent severe hypoglycaemia (as judged by the investigator)
- •Active proliferative retinopathy
- •Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
- •History of pancreatitis
研究组 & 干预措施
A
Experimental
干预措施: biphasic insulin aspart (Drug)
B
Active Comparator
干预措施: biphasic human insulin (Drug)
结局指标
主要结局
HbA1c (glycosylated haemoglobin A1c)
次要结局
- 8-point blood glucose profiles
- Incidence of hypoglycaemic episodes
- Occurrence of adverse events
研究者
研究点 (1)
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