Semaglutide, 0.5 mg/mL
DrugA single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
NCT Number: NCT03598621
This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Novo Nordisk Investigational Site, Mainz, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
Time frame: 0-840 hours (5 weeks)
Measured in nmol·h/L.
Time frame: 0-840 hours (5 weeks)
Measured in nmol/L.
Time frame: 0-840 hours (5 weeks)
Measured in nmol·h/L.
Time frame: 0-840 hours (5 weeks)
Measured in hours.
Time frame: 0-840 hours (5 weeks)
Measured in hours.
Time frame: 0-840 hours (5 weeks)
Measured in L/h.
Time frame: 0-840 hours (5 weeks)
Measured in L.
Time frame: Week 0-5 in both treatment period 1 and 2
Count of technical complaints.
Time frame: Week 0-5 in both treatment period 1 and 2
Count of technical complaints.
Novo Nordisk A/S
Industry
A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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