Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGInsulin icodec
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed