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NCT05790681CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
18 (actual)
First submitted
17 Mar 2023
Start date
25 Apr 2023
Primary completion date
8 Feb 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05790681

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 18
  • From 25 Apr 2023 to the primary completion date, 8 Feb 2024
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known or suspected hypersensitivity to study interventions or related products

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

Who the study is looking for

  • 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

Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Texas Tech University HSC
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AmarilloUnited StatesUnknown status
John Hopkins Univ Hosp
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BaltimoreUnited StatesUnknown status
Pennington Biom Res Ctr
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Baton RougeUnited StatesUnknown status
UBMD Peds-Div of Endo/Diabetes
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BuffaloUnited StatesUnknown status
UBMD Pediatrics
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BuffaloUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
University of Virginia Clinical Research Unit
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CharlottesvilleUnited StatesUnknown status
Childrens Hospital of Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Child's Hsp Med Ctr
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CincinnatiUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
University Of Iowa_Iowa City
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Iowa CityUnited StatesUnknown status
Nemours Chld Clnc Jacksonville
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JacksonvilleUnited StatesUnknown status
Nemours Children's Health
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JacksonvilleUnited StatesUnknown status
Children's Hosp-Los Angeles
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Los AngelesUnited StatesUnknown status
Children's Hospital Los Angeles - Endocrinology
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Los AngelesUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Yale New Haven Hospital, Hospital Research Unit
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New HavenUnited StatesUnknown status
Children's Hosp Of Phil
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
NE Clin Res of San Antonio
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SchertzUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.