Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
NCT Number: NCT03789578
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all 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 32 weeks in total.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
Other names: Ozempic®
Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
Time frame: 0-840 hours
Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Time frame: 0-840 hours
Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Time frame: 0-840 hours
Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Time frame: 0-840 hours
Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Time frame: 0-840 hours
Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Time frame: 0-840 hours
Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Time frame: 0-840 hours
Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Time frame: 0-840 hours
Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Time frame: Day 1 (beginning of each period) to day 36 (end of each period)
Count of events.
Time frame: Day 1 (beginning of each period) to day 36 (end of each period)
Count of episodes.
Time frame: Day -1 (pre-dose), Day 36 (end of period)
Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.
Time frame: Day 36 (end of period)
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Time frame: Day 36 (end of period)
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Time frame: Day -1 (pre-dose), Day 36 (end of period)
Measured as percentage B/T following administration of NNC0148 -0287sema
Time frame: Day 36 (end of period)
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Time frame: Day 36 (end of period)
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Time frame: Day 151 (follow-up/end-of-trial visit)
Measured as percentage B/T.
Time frame: Day 151 (follow-up/end-of-trial visit)
Percentage of events (yes/no).
Time frame: Day 151 (follow-up/end-of-trial visit)
Measured as percentage B/T.
Time frame: Day 151 (follow-up/end-of-trial visit)
Percentage of events (yes/no).
Time frame: Day 151 (follow-up/end-of-trial visit)
Percentage of events (yes/no).
Time frame: Day 151 (follow-up/end-of-trial visit)
Percentage of events (yes/no).
Novo Nordisk A/S
Industry
A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes
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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