A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin icodec


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with normal hepatic function<br>The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. | Drug: Insulin icodec<br>* 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.<br>|
| Experimental: Subjects with mild hepatic impairment, child-pugh grade A<br>The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. | Drug: Insulin icodec<br>* 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.<br>|
| Experimental: Subjects with moderate hepatic impairment, child-pugh grade B<br>The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. | Drug: Insulin icodec<br>* 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.<br>|
| Experimental: Subjects with severe hepatic impairment, child-pugh grade C<br>The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. | Drug: Insulin icodec<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose | From 0 hours until infinity after trial product administration (pmol*h/L) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose | From 0 hours until last measurement time after trial product administration (pmol/L) | Day 1 | 
| tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose | From 0 hours until last measurement time after trial product administration (hours) | Day 1 |