A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers

Study Overview
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Brief Summary
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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.

Official Title
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A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes

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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Type 2 Diabetes<br>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. | Drug: Insulin icodec<br>* Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD) | Measured in picomoles*hours per liter (pmol*h/L). | From 0 hours until infinity after trial product administration (day 1) | 
| Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD) | Measured in picomoles per liter (pmol/L). | From 0 hours until last measurement time after trial product administration (day 1) | 
| Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD) | Measured in hours. | From 0 hours until last measurement time after trial product administration (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model) | Measured in pmol/L. | From 0 to 168 hours after trial product administration | 
| Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model) | Measured in pmol*h/L. | From 0 to 168 hours after trial product administration |