NCT01002768已完成1 期
A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
研究概览
简要总结
This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.
The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index 18.0-28.0 kg/m^2 (both inclusive)
排除标准
- •Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
研究组 & 干预措施
IDeg
Experimental
干预措施: insulin degludec (Drug)
IGlar
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
时间窗: Within 0-46 hours after last trial product administration
次要结局
- Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose(Within 0-46 hours after last trial product administration)
- Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L(Within 0-46 hours after last trial product administration)
- Time from start of hypoglycaemic induction until each level of plasma glucose is reached(Within 0-46 hours after last trial product administration)
- Hypoglycaemic symptoms score during recovery from hypoglycaemia(Within 0-46 hours after last trial product administration)
研究者
研究点 (1)
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