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

Last updated 2026-05-28

This study is observing the safety and effectiveness of the diabetes medication Rybelsus (oral semaglutide) in adults with type 2 diabetes in real-world clinical settings in Korea.

Status Not yet recruiting Approved but enrollment has not started.

Type Observational

Participants 600 people Planned (estimated).

Who can join Ages 19+ · female only

Timeline Started 2025-12 · est. completion 2026-10

What this study is testing ClinicalTrials.gov NCT05714683 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide also known as Rybelsus 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.

Main thing measured	Number (Incidence) of adverse events (AEs)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05714683 ↗