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Clinical Trial Details

Trial ID: L3012
Source ID: NCT05473286
Associated Drug: Oral Semaglutide
Title: A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Acronym: PIONEER REAL
Status: WITHDRAWN
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 or No), Percentage of patients achieving or not achieving HbA1c \<7% (Yes or No)., 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 HbA1c reduction \>=1%-points and body weight reduction of \>=5%., 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 HbA1c reduction \>=1%-points and body weight reduction of \>=3%., From baseline (week 0) to End of Study visit (V3) (week 34-44)|Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), 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)|Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), 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: 0
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-09-30
Completion Date: 2024-05-16
Results First Posted:
Last Update Posted: 2022-09-29
Locations:
URL: https://clinicaltrials.gov/show/NCT05473286