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Clinical Trial Details

Trial ID: L6873
Source ID: NCT05714683
Associated Drug: Semaglutide
Title: 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
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: Number (Incidence) of adverse events (AEs), Measured as count of events., From baseline (week 0) to 26 weeks | Secondary: Number (Incidence) of hypoglycaemia Level 3 or Level 2, Hypoglycaemia Level 3 or Level 2 according to American Diabetes Association (ADA) guideline 2020 refers to: 1) Level 2: Glucose less than (\<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter \[mmol/L\]); 2) Level 3: A severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia. Measured as count of events., From baseline (week 0) to 26 weeks|Change in glycated haemoglobin (HbA1c), Measured in percentage (%)., From baseline (week 0) to 26 weeks|Participants achieving HbA1c target <7.0%, Measured as count of participants (Yes/No)., At 26 weeks|Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG), Measured in mg/dL., From baseline (week 0) to 26 weeks|Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG), Measured in mg/dL., From baseline (week 0) to 26 weeks|Change in body weight, Measured in kilogram (kg)., From baseline (week 0) to 26 weeks|Dose of Rybelsus, Measured in milligrams per day (mg/day)., At 26 weeks
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 600
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2025-03-31
Completion Date: 2026-10-30
Results First Posted:
Last Update Posted: 2025-01-30
Locations:
URL: https://clinicaltrials.gov/show/NCT05714683