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Clinical Trial Details

Trial ID: L5761
Source ID: NCT04537637
Associated Drug: Oral Semaglutide
Title: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Denmark, 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 (V3) (week 34-44) | Secondary: Relative change in body weight, Percent, 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 <7% (Yes/No), Percentage of patients achieving or not achieving the target value., End of Study visit (V3) (week 34-44)|HbA1c reduction >=1%-points and body weight reduction of >=5% (Yes/No), Percentage of patients achieving or not achieving the reduction., From baseline (week 0) to End of Study visit (V3) (week 34-44)|HbA1c reduction >=1%-points and body weight reduction of >=3% (Yes/No), Percentage of patients achieving or not achieving the reduction., From baseline (week 0) to End of Study visit (V3) (week 34-44)|Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction, The change version (DTSQc) has the same 8 items as the status version but is reworded to direct the patients to rate their change in treatment satisfaction compared to before being treated with oral semaglutide. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change., End of Study visit (V3) (week 34-44)|Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction, The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively., 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: 99
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-08-28
Completion Date: 2023-05-08
Results First Posted:
Last Update Posted: 2024-01-10
Locations: Master Centre for Denmark, Copenhagen S, 2300, Denmark|Novo Nordisk investigational site, Søborg, 2860, Denmark
URL: https://clinicaltrials.gov/show/NCT04537637