NCT02220296已完成1 期
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and 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
- 62
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a range of single doses of subcutaneous insulin 338.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trial Part 1 (Healthy subjects):
- •Male subject
- •Age 18-55 (both inclusive) at the time of signing inform consent
- •Body mass index 19.0-29.9 kg/m^2 (both inclusive)
- •Trial Part 2 (Subjects with type 1 diabetes mellitus):
- •Male subject or female subject of non-child bearing potential. Non-child bearing potential: being surgically sterilized (i.e. tubal ligation, bilateral oopherectomies or hysterectomised) for more than 3 months or being postmenopausal (as defined by amenorrhoea for at least 2 years prior to screening and documented by follicle-stimulating hormone (FSH) 40 U/L)
- •Age 18-64 years (both inclusive) at the time of signing inform consent
- •Body mass index 19.0-29.9 kg/m^2 (both inclusive)
- •Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- •Treated with multiple daily insulin injections or insulin pump treatment for 12 months or longer
- •Glycated hemoglobin (HbA1c) 9.0% or less
- •Fasting C-peptide less than 0.3 nmol/L
排除标准
- •Trial Part 1 (healthy subjects):
- •History of, or presence of, cancer, diabetes mellitus or any clinically significant cardiovascular, respiratory, metabolic (including dyslipidemia), renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator
- •Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods
- •Trial Part 2 (subjects with type 1 diabetes mellitus):
- •History of, or presence of, cancer or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, venereal, neurological, psychiatric, other major disorders or personal and/or family history of thromboembolism, as judged by the investigator
- •Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the past 6 months before start of this trial (screening)
- •Cardiac problems defined as: 1) decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time, or 2) acute myocardial infarction at any time, or 3) angina pectoris within the last 12 months before start of this trial (screening)
- •Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods.
研究组 & 干预措施
Part 1 insulin 338
Experimental
干预措施: Insulin 338 (Drug)
Part 1 placebo
Placebo Comparator
干预措施: placebo (Drug)
Part 2 insulin 338
Experimental
干预措施: Insulin 338 (Drug)
Part 2 insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Day 1 - day 22
次要结局
- t1/2, the terminal half-life of insulin 338(Day 1- day 22)
- Time for maximum serum insulin 338 concentration(Day 1- day 22)
- Maximum serum insulin 338 concentration observed(Day 1- day 22)
- Area under the serum insulin 338 concentration-time curve from zero to infinity(Day 1- day 22)
- Incidence of hypoglycaemic episodes(Day 1 - day 22)
研究者
研究点 (1)
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