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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT05790681

Run by

Novo Nordisk A/S

People needed

18

Starts

2023-04-25

Expected to finish

2024-02-08

Last updated by the study team

2026-04-09

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.