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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
Children's Hosp-Los Angeles
Los Angeles, California, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Yale New Haven Hospital, Hospital Research Unit
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Nemours Children's Health
Jacksonville, Florida, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, United States
Childrens Hospital of Chicago
Chicago, Illinois, United States
University Of Iowa_Iowa City
Iowa City, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States
...and 11 more locations
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).
Time frame: From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Measured in picomoles per liter (pmol/L).
Time frame: From 0 hours until last measurement time after trial product administration (day 1)
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Measured in hours.
Time frame: From 0 hours until last measurement time after trial product administration (day 1)
Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
Measured in pmol/L.
Time frame: From 0 to 168 hours after trial product administration
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Measured in pmol\*h/L.
Time frame: From 0 to 168 hours after trial product administration
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