NCT03220425已完成3 期
A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.
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
- 752
- 试验地点
- 1
- 主要终点
- The change in the level of glycosylated haemoglobin(HbA1c)
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed and dated informed consent obtained before any trial-related activities
- •Type 1 diabetes diagnosed and classified according to aetiology
- •Duration of type 1 diabetes equal to or more than 12 months
- •Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
- •Able and willing to perform self-blood glucose monitoring
排除标准
- •Proliferative retinopathy
- •Total basal insulin dose of more than 100 IU per day
- •Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
- •Known unawareness of hypoglycaemia
- •Previous treatment with insulin detemir
研究组 & 干预措施
NPH insulin
Active Comparator
干预措施: NPH insulin (Drug)
Insulin detemir
Experimental
干预措施: Insulin detemir (Drug)
结局指标
主要结局
The change in the level of glycosylated haemoglobin(HbA1c)
时间窗: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
次要结局
未报告次要终点
研究者
研究点 (1)
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