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
- Diseases
- Type 2 diabetes
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Tech University HSC Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| John Hopkins Univ Hosp Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Pennington Biom Res Ctr Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| UBMD Peds-Div of Endo/Diabetes Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| UBMD Pediatrics Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Virginia Clinical Research Unit Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Childrens Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Child's Hsp Med Ctr Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University Of Iowa_Iowa City Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Nemours Chld Clnc Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Nemours Children's Health Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children's Hosp-Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital Los Angeles - Endocrinology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Yale New Haven Hospital, Hospital Research Unit Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Children's Hosp Of Phil Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| NE Clin Res of San Antonio Coordinator of this site? Confirm its status | Schertz | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.