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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05714683
• Other study ID #: NN9924-4652
• Secondary ID: U1111-1243-9500
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: October 30, 2026

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2026
• Gender: Female
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Change in glycated haemoglobin (HbA1c)	Measured in percentage (%).	From baseline (week 0) to 26 weeks
Secondary	Participants achieving HbA1c target <7.0%	Measured as count of participants (Yes/No).	At 26 weeks
Secondary	Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)	Measured in mg/dL.	From baseline (week 0) to 26 weeks
Secondary	Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)	Measured in mg/dL.	From baseline (week 0) to 26 weeks
Secondary	Change in body weight	Measured in kilogram (kg).	From baseline (week 0) to 26 weeks
Secondary	Dose of Rybelsus	Measured in milligrams per day (mg/day).	At 26 weeks