Clinical trial NCT05790681: A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
Official title: A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
timeFrame: From 0 hours until infinity after trial product administration (day 1)
measure: Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
timeFrame: From 0 hours until last measurement time after trial product administration (day 1)
measure: Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
timeFrame: From 0 hours until last measurement time after trial product administration (day 1)
Secondary outcomes:
measure: Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
timeFrame: From 0 to 168 hours after trial product administration
measure: Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
timeFrame: From 0 to 168 hours after trial product administration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hosp-Los Angeles
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles - Endocrinology
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital, Hospital Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Nemours Children's Health
state: Florida
city: Jacksonville
country: United States
facility: Nemours Chld Clnc Jacksonville
state: Florida
city: Baton Rouge
country: United States
facility: Pennington Biom Res Ctr
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins Univ Hosp
state: Maryland
city: Buffalo
country: United States
facility: UBMD Peds-Div of Endo/Diabetes
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Child's Hsp Med Ctr
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia Clinical Research Unit
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: