The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
NNC0363-1063 will be administered subcutaneously.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
RECRUITINGAUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
Measured in milligrams per kilogram (mg/kg).
Time frame: Visit 2 and 3: Day 2 and 3
GIRmax,SS: Maximum glucose infusion rate at steady state
Measured in milligrams per kilogram\*minute (mg/\[kg\*min\]).
Time frame: Visit 2 and 3: Day 2 and 3
Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state
Measured in hours.
Time frame: Visit 2 and 3: Day 2 and 3
AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state
Measured in hours\*picomoles per litre (h\*pmol/L).
Time frame: Visit 2 and 3: Day 2 and 3
Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state
Measured in picomoles per litre (pmol/L).
Time frame: Visit 2 and 3: Day 2 and 3
tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state
Measured in hours.
Time frame: Visit 2 and 3: Day 2 and 3
Number of adverse events
Measured as number of events.
Time frame: Visit 2 and 3: Day 2 and 3
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