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

April 3, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hosp-Los Angeles
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles - Endocrinology
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital, Hospital Research Unit
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Health
      • Jacksonville, Florida, United States, 32207
        • Nemours Chld Clnc Jacksonville
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Childrens Hospital of Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa_Iowa City
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biom Res Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Univ Hosp
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Pediatrics
      • Buffalo, New York, United States, 14203
        • UBMD Peds-Div of Endo/Diabetes
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Child's Hsp Med Ctr
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hosp Of Phil
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University HSC
      • Schertz, Texas, United States, 78154
        • NE Clin Res of San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: From 0 hours until infinity after trial product administration (day 1)
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)
Time Frame: From 0 hours until last measurement time after trial product administration (day 1)
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)
Time Frame: From 0 hours until last measurement time after trial product administration (day 1)
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)
Time Frame: From 0 to 168 hours after trial product administration
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)
Time Frame: From 0 to 168 hours after trial product administration
Measured in pmol*h/L.
From 0 to 168 hours after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4888
  • U1111-1271-9231 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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