NCT01868529已完成1 期
A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus
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
- 63
- 主要终点
- Area under the glucose infusion rate curve
研究概览
简要总结
This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
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 69 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) and treated with insulin for at least 12 months
- •Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- •Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
- •Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
- •Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
- •Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
研究组 & 干预措施
Low dose
Experimental
干预措施: insulin degludec (Drug)
Low dose
Experimental
干预措施: insulin glargine (Drug)
Medium dose
Experimental
干预措施: insulin degludec (Drug)
Medium dose
Experimental
干预措施: insulin glargine (Drug)
High dose
Experimental
干预措施: insulin degludec (Drug)
High dose
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
时间窗: 0-24 hours in steady-state
次要结局
- Area under the serum insulin concentration curve at steady state(0-24 hours after dosing)
研究者
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