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Completed

NCT Number: NCT05790681

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hosp-Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin icodec

Drug

Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.

Primary outcomes

  1. Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)

    Time frame: From 0 hours until infinity after trial product administration (day 1)

    Measured in picomoles*hours per liter (pmol*h/L).

  2. Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)

    Time frame: From 0 hours until last measurement time after trial product administration (day 1)

    Measured in picomoles per liter (pmol/L).

  3. Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)

    Time frame: From 0 hours until last measurement time after trial product administration (day 1)

    Measured in hours.

Secondary outcomes

  1. Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)

    Time frame: From 0 to 168 hours after trial product administration

    Measured in pmol/L.

  2. Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)

    Time frame: From 0 to 168 hours after trial product administration

    Measured in pmol*h/L.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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