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Clinical Trial Details

Trial ID: L6597
Source ID: NCT04878393
Associated Drug: Oral Semaglutide
Title: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice
Acronym: PIONEER REAL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral semaglutide
Outcome Measures: Primary: Change in glycated haemoglobin (HbA1c), percent-points, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|Number of adverse event (AEs), Count, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44) | Secondary: Relative change in body weight, percent, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|Absolute change in body weight, Kilogram (Kg), From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|HbA1c less than 7 percent (Yes/No), Percentage of patients achieving or not achieving the target value, End of Study visit (Visit 3) (week 34-44)|HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No), Percentage of patients achieving or not achieving the target value, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No), Percentage of patients achieving or not achieving the target value, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|Number of adverse reactions (ARs), Count, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)|Number of serious adverse events (SAEs), Count, From baseline (week 0) to End of Study visit (Visit3) (week 34-44)|Number of serious adverse reactions (SARs), Count, From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 650
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-04-30
Completion Date: 2023-02-09
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Master Centre for Japan, Tokyo, 1000005, Japan
URL: https://clinicaltrials.gov/show/NCT04878393