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Clinical Trial Details

Trial ID: L2859
Source ID: NCT05443568
Associated Drug: Oral Semaglutide
Title: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Israel, as Part of Local Clinical Practice
Acronym: PIONEER REAL
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral semaglutide
Outcome Measures: Primary: Change in HbA1c (Glycated haemoglobin), Measured as percent-points, From baseline (week 0) to End of Study visit (V3) (week 34-44) | Secondary: Relative change in body weight, Measured as Percent, From baseline (week 0) to End of Study visit (V3) (week 34-44)|Absolute change in body weight, Measured in Kilogram (Kg), From baseline (week 0) to End of Study visit (V3) (week 34-44)|HbA1c below 7%, Percentage of participants achieving or not achieving the target value, 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%, Percentage of participants achieving or not achieving the reduction, 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%, Percentage of patients achieving or not achieving the reduction, From baseline (week 0) to End of Study visit (V3) (week 34-44)|DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction, The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction., End of Study visit (V3) (week 34-44)|DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction, The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items., From baseline (week 0) to End of Study visit (V3) (week 34-44)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 194
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-03-09
Completion Date: 2024-11-03
Results First Posted:
Last Update Posted: 2023-12-26
Locations: Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel
URL: https://clinicaltrials.gov/show/NCT05443568