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Clinical Trial Details

Trial ID: L5668
Source ID: NCT04152915
Associated Drug: Semaglutide
Title: A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Volunteers|Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period, hours\*nmol/L, 0-840 hours after one dose of s.c. semaglutide 1 mg|Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period, nmol/L, 0-840 hours after one dose of s.c. semaglutide 1 mg | Secondary: AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration, hours\*nmol/L, 0-168 hours after the last dose of s.c. semaglutide 0.25 mg|Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration, nmol/L, 0-168 hours after the last dose of s.c. semaglutide 0.25 mg|AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period, hours\*nmol/L, 0-840 hours after one dose of s.c. semaglutide 1 mg|tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period, hours, 0-840 hours after one dose of s.c. semaglutide 1 mg|tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration, hours, 0-168 hours after the last dose of s.c. semaglutide 0.25 mg|t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period, hours, 0-840 hours after one dose of s.c. semaglutide 1 mg
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-11-25
Completion Date: 2020-05-25
Results First Posted:
Last Update Posted: 2021-11-10
Locations: Novo Nordisk Investigational Site, Mainz, 55116, Germany
URL: https://clinicaltrials.gov/show/NCT04152915