A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 31
- 主要终点
- Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
研究概览
简要总结
Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. The study will last for about 8 weeks. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 milliliter (mL) (a little less than a quarter of a teaspoonful). The amount of insulin icodec participant will receive depends on participant's body weight. Participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 10 to less than (<) 18 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 30 days prior to the day of screening
- •Glycated haemoglobin (HbA1c) less than or equal to (<=) 10% (86 millimoles per mole [mmol/mol]) at screening
- •Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s).
- •Current daily basal insulin treatment >= 0.2 (I) units per kilogram per day (U/kg/day) with stable doses >=30 days prior to the day of screening
排除标准
- •Known or suspected hypersensitivity to study interventions or related products
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
研究组 & 干预措施
Participants with Type 2 Diabetes
Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing.
干预措施: Insulin icodec (Drug)
结局指标
主要结局
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
时间窗: From 0 hours until last measurement time after trial product administration (day 1)
Measured in picomoles per liter (pmol/L).
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
时间窗: From 0 hours until last measurement time after trial product administration (day 1)
Measured in hours.
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
时间窗: From 0 hours until infinity after trial product administration (day 1)
Measured in picomoles\*hours per liter (pmol\*h/L).
次要结局
- Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)(From 0 to 168 hours after trial product administration)
- Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)(From 0 to 168 hours after trial product administration)