NCT00604344已完成3 期
A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring 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
- •Duration of diabetes mellitus for at least 2 years
- •Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
- •HbA1C below 11.0%
排除标准
- •Impaired renal function
- •Impaired hepatic function
- •Serious heart diseases
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Uncontrolled treated/untreated hypertension
- •Current treatment with total insulin dose of more than 100 IU/day
- •Current treatment or expected at the screening to start treatment with systemic corticosteroids
结局指标
主要结局
HbA1c
时间窗: after 48 weeks of treatment
次要结局
- Blood glucose profiles
- Hypoglycaemic episodes
- Adverse events
- Body weight
- Insulin antibodies
研究者
研究点 (2)
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