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NCT05714683Not yet recruiting

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

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, 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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Rybelsus as prescribed by study doctor. The study will last for about 26 weeks.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
27 Jan 2023
Start date
31 Jan 2027
Primary completion date
30 Aug 2027
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05714683

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 31 Jan 2027 to the primary completion date, 30 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who are or have previously been on Rybelsus therapy
  • Previous participation in this study. Participation is defined as having given informed consent in this study

Other illness

  • Known or suspected hypersensitivity to Rybelsus, the active substance or any of the excipients
  • Family or personal history of multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)

Other

  • 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

Who the study is looking for

  • The decision to initiate treatment with commercially available Rybelsus has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • 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

Age in the registry: 19 years to - · Sex: Female

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.