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

NCT05790681 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN1436-4888U1111-1271-9231
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)

  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)

  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)

  Measured in hours.

  From 0 hours until last measurement time after trial product administration (day 1)

Secondary Outcomes (2)

• Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)

  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)

  From 0 to 168 hours after trial product administration

Study Arms (1)

Participants with Type 2 Diabetes

EXPERIMENTAL

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

Interventions

Insulin icodec DRUG

Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.

Participants with Type 2 Diabetes

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (21)

Children's Hosp-Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, 90027, United States

Location

Yale New Haven Hospital, Hospital Research Unit

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Nemours Children's Health

Jacksonville, Florida, 32207, United States

Location

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, 32207, United States

Location

Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University Of Iowa_Iowa City

Iowa City, Iowa, 52242, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Pennington Biom Res Ctr

Baton Rouge, Louisiana, 70808, United States

Location

John Hopkins Univ Hosp

Baltimore, Maryland, 21287, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, 14203, United States

Location

Cincinnati Child's Hsp Med Ctr

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hosp Of Phil

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh Of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Tech University HSC

Amarillo, Texas, 79106, United States

Location

NE Clin Res of San Antonio

Schertz, Texas, 78154, United States

Location

University of Virginia Clinical Research Unit

Charlottesville, Virginia, 22908, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: April 25, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (21)