This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes. IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide. Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan. The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide. Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints: The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Peking University Third Hospital, Northern branch-Phase I
Beijing, Beijing Municipality, China
AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours\*pmol/L
Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Measured in (hours\*nmol/L)/mg
Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours\*pmol/L
Time frame: From 0 hours to infinity after IMP administration (day 1)
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose
Measured in pmol/L
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose
Measured in hours
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Ico: Terminal half-life for insulin icodec after a single dose
Measured in hours
Time frame: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Measured in (hours\*nmol/L)/mg
Time frame: From 0 hours to infinity after IMP administration (day 1)
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose
Measured in (nmol/L)/mg
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose
Measured in hours
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Sema: Terminal half-life for semaglutide after a single dose
Measured in hours
Time frame: Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Adverse events
Number of events
Time frame: From IMP administration (day 1) to end of follow-up for each treatment period (day 36)
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