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

Sponsor
Novo Nordisk A/S
Study ID
NCT05714683
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

Number (Incidence) of adverse events (AEs) [ Time Frame: From baseline (week 0) to 26 weeks ]

Central Contacts

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