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Clinical Trial Details

Trial ID: L7129
Source ID: NCT05435677
Associated Drug: Icosema
Title: A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IcoSema|DRUG: insulin icodec|DRUG: semaglutide
Outcome Measures: Primary: AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose, Measured in hours\*pmol/L, 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, From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration | Secondary: AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose, Measured in hours\*pmol/L, 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, 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, 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, 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, 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, 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, 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, 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, From IMP administration (day 1) to end of follow-up for each treatment period (day 36)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-22
Completion Date: 2023-04-25
Results First Posted:
Last Update Posted: 2025-03-21
Locations: Peking University Third Hospital, Northern branch-Phase I, Beijing, Beijing, 100089, China
URL: https://clinicaltrials.gov/show/NCT05435677