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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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Oct 30, 2026 → Aug 30, 2027
See other at-risk trials from Novo Nordisk

Record History

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  1. Primary completion pushed from Oct 30, 2026 to Aug 30, 2027 Show 5 more changesShow less
    • Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Start date: Dec 31, 2025 to Jan 31, 2027
    • Study completion pushed from Oct 30, 2026 to Oct 31, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 7 entries
  2. Start date: Mar 31, 2025 to Dec 31, 2025v5
  3. Start date: Dec 31, 2024 to Mar 31, 2025v4
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Jan 31, 2023 to Dec 31, 2024v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
268 trials monitored
See 15 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
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 Details
NCT Number NCT05714683
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov