Diabetes Mellitus, Type 2
Conditions
Brief summary
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit. 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 mL (about a spoonful). Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ). Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Interventions
DRUGInsulin icodec
Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Aged 18-70 years (both inclusive) at the time of signing informed consent * Body mass index between 18.5 and 39.9 kg/m\^2 (both inclusive) Specific inclusion criterion only for subjects with hepatic impairment * Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to trial product 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) * Diagnosis of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose | Day 1 | From 0 hours until infinity after trial product administration (pmol\*h/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose | Day 1 | From 0 hours until last measurement time after trial product administration (pmol/L) |
| tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose | Day 1 | From 0 hours until last measurement time after trial product administration (hours) |
Countries
Czechia, Slovakia
Outcome results
None listed