Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
NCT ID: NCT05714683
Last Updated: 2025-12-05
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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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2025-12-31
2026-10-30
Brief Summary
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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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Participants with T2DM
All participants will be treated with Rybelsus for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by Ministry of Food and Drug Safety (MFDS).
Semaglutide
All participants will be treated with oral semaglutide for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The prescription of semaglutide will be separated from the decision to include the participant in the study.
Interventions
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Semaglutide
All participants will be treated with oral semaglutide for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The prescription of semaglutide will be separated from the decision to include the participant in the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant with T2DM is scheduled to start treatment with Rybelsus based on the clinical judgment of their treating physician as specified in the approved label in Korea
* Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
* Male/female age greater than or equal to (\>=) 19 years at the time of signing informed consent
Exclusion Criteria
* Known or suspected hypersensitivity to Rybelsus, the active substance or any of the excipients
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Female participant who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Family or personal history of multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
19 Years
FEMALE
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. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Central Contacts
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Other Identifiers
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U1111-1243-9500
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4652
Identifier Type: -
Identifier Source: org_study_id
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