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Not yet recruiting NCT05714683

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

— Observational Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Number (Incidence) of adverse events (AEs) [Time frame: From baseline (week 0) to 26 weeks]
Secondary outcome measures (7)
  • Number (Incidence) of hypoglycaemia Level 3 or Level 2 [Time frame: From baseline (week 0) to 26 weeks]
  • Change in glycated haemoglobin (HbA1c) [Time frame: From baseline (week 0) to 26 weeks]
  • Participants achieving HbA1c target <7.0% [Time frame: At 26 weeks]
  • Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) [Time frame: From baseline (week 0) to 26 weeks]
  • Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) [Time frame: From baseline (week 0) to 26 weeks]
  • Change in body weight [Time frame: From baseline (week 0) to 26 weeks]
  • Dose of Rybelsus [Time frame: At 26 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Participants who are or have previously been on Rybelsus therapy
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05714683 · NN9924-4652 · U1111-1243-9500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗