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Clinical Trial Details

Trial ID: L5617
Source ID: NCT05230615
Associated Drug: Oral Semaglutide
Title: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Italy, 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 HbA1c (Glycated haemoglobin), %-points, From baseline (week 0) to End of Study visit (V3) (week 34-44) | Secondary: Relative change in body weight, From baseline (week 0) to End of Study visit (V3) (week 34-44)|Absolute change in body weight, Kilogram (Kg), From baseline (week 0) to End of Study visit (V3) (week 34-44)|HbA1c below 7%, Yes or No, End of Study visit (V3) (week 34-44)|HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5%, Yes or No, From baseline (week 0) to End of Study visit (V3) (week 34-44)|HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3%, Yes or No, From baseline (week 0) to End of Study visit (V3) (week 34-44)|DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction, Total score, End of Study visit (V3) (week 34-44)|DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction From baseline (week 0) to, Total score, End of Study visit (V3) (week 34-44)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 458
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-11-21
Completion Date: 2023-11-03
Results First Posted:
Last Update Posted: 2023-12-26
Locations: Novo Nordisk Investigational Site, Rome, 00144, Italy|Novo Nordisk Investigational Site, Sesto San Giovanni, Italy
URL: https://clinicaltrials.gov/show/NCT05230615