A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice
NCT ID: NCT04601740
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
145 participants
OBSERVATIONAL
2020-11-17
2022-12-19
Brief Summary
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Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Oral Semaglutide
Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
Interventions
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Oral Semaglutide
Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days
Exclusion Criteria
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Master Centre Netherlands
Alphen aan den Rijn, , Netherlands
Countries
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References
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Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.
van Houtum W, Schrombges P, Amadid H, van Bon AC, Braae UC, Hoogstraten C, Herrings H. Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study. Diabetes Ther. 2024 Aug;15(8):1749-1768. doi: 10.1007/s13300-024-01588-5. Epub 2024 Jun 11.
Other Identifiers
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U1111-1240-4249
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4643
Identifier Type: -
Identifier Source: org_study_id
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