NCT00184665已完成3 期
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 30
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
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 1 diabetes
- •Currently on basal-bolus regimen
- •BMI = 35.0 kg/m2
- •HbA1c =11.0%
排除标准
- •Proliferative retinopathy or maculopathy
- •Recurrent major hypoglycaemia
- •Cardial problems
- •Uncontrolled hypertension
- •Impaired hepatic or renal function
结局指标
主要结局
HbA1c
时间窗: after a two-year trial period
次要结局
- Hypoglycaemia
- Body composition
- Blood glucose
- Body weight
- Antibodies
- Adverse events
研究者
研究点 (30)
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