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Clinical Trial Details

Trial ID: L5573
Source ID: NCT04524832
Associated Drug: Oral Semaglutide
Title: Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral semaglutide
Outcome Measures: Primary: Area under the semaglutide plasma concentration - time curve during a dosing interval at steady state (AUC0-24h,sema,SS), nmol\*h/L, From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84|Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS), nmol\*h/L, From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112 | Secondary: Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (AUC0-24h,sema,SS), nmol\*h/L, From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56.|Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), nmol/L, From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56|Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), nmol/L, From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84|Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), nmol/L, From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112|Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS), hour, From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84|Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS), hour, From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112|Number of treatment-emergent adverse events, Count, From the time of first dosing (visit 2, day 1) until completion of the follow-up visit (visit 11, day 149)|Change in pulse, Beats/minute, From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)|Change in blood pressure, mmHg, From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 290
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-29
Completion Date: 2022-02-25
Results First Posted:
Last Update Posted: 2023-10-10
Locations: Novo Nordisk Investigational Site, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT04524832