Clinical trial

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

Name

NN9924-4652

Description

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.

Trial arms

Trial start

2024-12-31

Estimated PCD

2026-10-30

Trial end

2026-10-30

Status

Not yet recruiting

Treatment

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.

Arms:

Participants with T2DM

Other names:

Rybelsus

Size

600

Primary endpoint

Number (Incidence) of adverse events (AEs)

From baseline (week 0) to 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)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

Updated at

2024-05-01

1 organization

1 product

2 indications

Organization

Product

Indication

Indication