This study compares semaglutide in two different injection tools called "PDS290" and "DV3372". The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools. The researchers also want to look at how well the injection tools work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection tool. This is decided by chance, like flipping a coin. This is called randomisation. Semaglutide is an approved medicine (thus available on the market) for people with type 2 diabetes. Semaglutide will be injected subcutaneously (injection under the skin). Participants will get a total of 5 injections with semaglutide. The study will last for a maximum of 86 days. Participants will have 17 scheduled site visits with the study physician or study staff at the study centre. For one of the visits participants will stay at the research unit for 4 days and 3 nights. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men and women are allowed to take part. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Semaglutide will be administered subcutaneously (s.c., under the skin) on day 1 and 8 in the morning after an overnight fast of at least 8 hours
Semaglutide will be administered s.c. (under the skin) on day 15 and 22 in the morning after an overnight fast of at least 8 hours
Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours
DV3372 device will be used for administration of semaglutide
PDS290 pen-injector will be used for administration of semaglutide
Novo Nordisk Investigational Site
Berlin, Germany
AUC0-last,sema,Week5: the area under the plasma semaglutide concentration-time curve from 0 until last quantifiable measurement after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period
Measured in nmol\*h/L
Time frame: 0-840 hours (5 weeks)
Cmax,sema,Week5: the maximum plasma semaglutide concentration after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period
Measured in nmol/L
Time frame: 0-840 hours (5 weeks)
tmax,sema,Week5: time to Cmax of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period
Measured in hours
Time frame: 0-840 hours (5 weeks)
t½,sema,Week5: terminal elimination half-life of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period
Measured in hours
Time frame: 0-840 hours (5 weeks)
Number of site-initiated technical complaints with or without co-reported adverse events
Number of technical complaints
Time frame: from first semaglutide dose (day 1) and until the follow-up visit (5 weeks after the last dose of semaglutide)
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