NCT01114542已完成1 期
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions 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
- 66
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state
研究概览
简要总结
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
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
- •Current total daily insulin treatment lower than 1.2 (I)U/kg/day
- •Body mass index 18.0-28.0 kg/m^2
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
- •Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
研究组 & 干预措施
IDeg 0.4 U/kg
Experimental
干预措施: insulin degludec (Drug)
IDeg 0.6 U/kg
Experimental
干预措施: insulin degludec (Drug)
IDeg 0.8 U/kg
Experimental
干预措施: insulin degludec (Drug)
IGlar 0.4 U/kg
Active Comparator
干预措施: insulin glargine (Drug)
IGlar 0.6 U/kg
Active Comparator
干预措施: insulin glargine (Drug)
IGlar 0.8 U/kg
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state
时间窗: 0-24 hours after dosing on day 8
次要结局
- Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state(0-24 hours after dosing on day 8)
- Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec(0-24 hours after dosing on day 8)
- Area under the concentration-time curve during one dosing interval at steady state for insulin glargine(0-24 hours after dosing on day 8)
研究者
研究点 (1)
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