NCT01650129已完成3 期
An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in 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
- 83
- 试验地点
- 1
- 主要终点
- Glycosylated haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 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
- •Subjects with insulin treated for at least 24 weeks
- •HbA1c maximum 11.0%
- •Body mass index (BMI) below 30.0 kg/m^2
- •Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes
排除标准
- •Recurrent severe hypoglycaemia
- •Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac diseases
- •Uncontrolled hypertension
- •Subjects with history of severe allergic or severe hypersensitive reactions
- •Total daily insulin dose at least 100 IU
- •Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
研究组 & 干预措施
BIAsp
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
BHI
Experimental
干预措施: biphasic human insulin 50 (Drug)
结局指标
主要结局
Glycosylated haemoglobin A1c (HbA1c)
次要结局
- Blood glucose
- Change from baseline in insulin antibodies
- Incidence of hypoglycaemic episodes
- Occurrence of adverse event(s)
- Insulin doses
研究者
研究点 (1)
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