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New insulin studied in kids with type 2 diabetes – first look at how it works

NCT ID NCT05790681

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new insulin called insulin icodec in 18 children and teenagers (ages 10 to 17) with type 2 diabetes. Each participant received a single injection based on their body weight, and researchers measured how the insulin moved through their blood over time. The goal was to understand the drug's behavior in younger people, not to treat or cure diabetes. This is an early-stage study, so the insulin is not yet available in pharmacies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Apr 2023

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Children's Hosp Of Phil

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hosp-Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hospital of Pittsburgh Of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Childrens Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Cincinnati Child's Hsp Med Ctr

    Cincinnati, Ohio, 45229, United States

  • John Hopkins Univ Hosp

    Baltimore, Maryland, 21287, United States

  • NE Clin Res of San Antonio

    Schertz, Texas, 78154, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Health

    Jacksonville, Florida, 32207, United States

  • Nemours Chld Clnc Jacksonville

    Jacksonville, Florida, 32207, United States

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808, United States

  • Texas Tech University HSC

    Amarillo, Texas, 79106, United States

  • UBMD Pediatrics

    Buffalo, New York, 14203, United States

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203, United States

  • University Of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Virginia Clinical Research Unit

    Charlottesville, Virginia, 22908, United States

  • Yale New Haven Hospital, Hospital Research Unit

    New Haven, Connecticut, 06510, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.