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

NCT05714683 | Not Yet Recruiting

• 2 other identifiers: NN9924-4652U1111-1243-9500
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number (Incidence) of adverse events (AEs)

  Measured as count of events.

  From baseline (week 0) to 26 weeks

Secondary Outcomes (7)

• Number (Incidence) of hypoglycaemia Level 3 or Level 2

  From baseline (week 0) to 26 weeks

• Change in glycated haemoglobin (HbA1c)

  From baseline (week 0) to 26 weeks

• Participants achieving HbA1c target <7.0%

  At 26 weeks

• Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)

  From baseline (week 0) to 26 weeks

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

  From baseline (week 0) to 26 weeks

Study Arms (1)

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).

Drug: Semaglutide

Interventions

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.

Also known as: Rybelsus

Participants with T2DM

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: December 31, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share