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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790681
• Other study ID #: NN1436-4888
• Secondary ID: U1111-1271-9231
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2023
• Est. completion date: February 8, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	John Hopkins Univ Hosp	Baltimore	Maryland
United States	Pennington Biom Res Ctr	Baton Rouge	Louisiana
United States	UBMD Peds-Div of Endo/Diabetes	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Cincinnati Child's Hsp Med Ctr	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Nemours Chld Clnc Jacksonville	Jacksonville	Florida
United States	Children's Hosp-Los Angeles	Los Angeles	California
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)	Measured in pmol/L.	From 0 to 168 hours after trial product administration
Secondary	Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,t,SS,model)	Measured in pmol*h/L.	From 0 to 168 hours after trial product administration