A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
研究概览
简要总结
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
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
- None
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
- •Male or female
- •Aged 18-69 years (both inclusive) at the time of signing informed consent
- •Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
- •Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
- •HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
- •Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
- •Any metformin formulation
- •Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
- •Oral or injectable GLP-1 (glucagon-like peptide 1) Receptor Agonists
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
研究组 & 干预措施
Insulin icodec treatment sequence with injection region abdomen
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
干预措施: Insulin icodec (Drug)
Insulin icodec treatment sequence with injection region upper arm
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
干预措施: Insulin icodec (Drug)
Insulin icodec treatment sequence with injection region thigh
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
干预措施: Insulin icodec (Drug)
结局指标
主要结局
AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
时间窗: Day 1
From 0 hours until infinity after trial product administration (pmol\*h/L)
次要结局
- Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose(Day 1)
- tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose(Day 1)