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NCT Number: 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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semaglutide

Drug

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 names: Rybelsus

Primary outcomes

  1. Number (Incidence) of adverse events (AEs)

    Time frame: From baseline (week 0) to 26 weeks

    Measured as count of events.

Secondary outcomes

  1. Number (Incidence) of hypoglycaemia Level 3 or Level 2

    Time frame: From baseline (week 0) to 26 weeks

    Hypoglycaemia Level 3 or Level 2 according to American Diabetes Association (ADA) guideline 2020 refers to: 1) Level 2: Glucose less than (<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter [mmol/L]); 2) Level 3: A severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia. Measured as count of events.

  2. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to 26 weeks

    Measured in percentage (%).

  3. Participants achieving HbA1c target <7.0%

    Time frame: At 26 weeks

    Measured as count of participants (Yes/No).

  4. Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to 26 weeks

    Measured in mg/dL.

  5. Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)

    Time frame: From baseline (week 0) to 26 weeks

    Measured in mg/dL.

  6. Change in body weight

    Time frame: From baseline (week 0) to 26 weeks

    Measured in kilogram (kg).

  7. Dose of Rybelsus

    Time frame: At 26 weeks

    Measured in milligrams per day (mg/day).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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