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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05790681

Collaborator

(none)

Enrollment

Locations

Arm

34.1

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin icodec	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Jan 21, 2026

Anticipated Study Completion Date :

Jan 21, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Type 2 Diabetes 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 Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.

Arm

Intervention/Treatment

Experimental: Participants with Type 2 Diabetes

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

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

Outcome Measures

Primary Outcome Measures

Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD) [From 0 hours until infinity after trial product administration (day 1)]
Measured in picomoles*hours per liter (pmol*h/L).
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD) [From 0 hours until last measurement time after trial product administration (day 1)]
Measured in picomoles per liter (pmol/L).
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD) [From 0 hours until last measurement time after trial product administration (day 1)]
Measured in hours.

Secondary Outcome Measures

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]
Measured in pmol/L.
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]
Measured in pmol*h/L.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Los Angeles	California	United States	90027
2	Novo Nordisk Investigational Site	New Haven	Connecticut	United States	06511
3	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32207
4	Novo Nordisk Investigational Site	Baton Rouge	Louisiana	United States	70808
5	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21287
6	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
7	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45229
8	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43205
9	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
10	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
11	Novo Nordisk Investigational Site	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05790681

Other Study ID Numbers:

NN1436-4888
U1111-1271-9231

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Insulin

Study Results

No Results Posted as of Mar 30, 2023