A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
- Registration Number
- NCT05790681
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with Type 2 Diabetes Insulin icodec 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.
- Primary Outcome Measures
Name Time Method 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.
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).
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (13)
Children's Hospital Los Angeles - Endocrinology
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital, Hospital Research Unit
🇺🇸New Haven, Connecticut, United States
Nemours Children's Health
🇺🇸Jacksonville, Florida, United States
University of Virginia Clinical Research Unit
🇺🇸Charlottesville, Virginia, United States
Children's Hosp-Los Angeles
🇺🇸Los Angeles, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Nemours Chld Clnc Jacksonville
🇺🇸Jacksonville, Florida, United States
Pennington Biom Res Ctr
🇺🇸Baton Rouge, Louisiana, United States
John Hopkins Univ Hosp
🇺🇸Baltimore, Maryland, 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
University of Virginia
🇺🇸Charlottesville, Virginia, United States