NCT02938572已完成1 期
Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 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
- 47
- 试验地点
- 1
- 主要终点
- The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-55 years (both inclusive) at the time of signing informed consent
- •Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- •Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)
研究组 & 干预措施
NNC0143-0406
Experimental
干预措施: NNC0143-0406 (Drug)
Insulin aspart
Active Comparator
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
时间窗: Two weeks of treatment
次要结局
- Number of treatment emergent adverse events(Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration)
研究者
研究点 (1)
Loading locations...
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