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

April 30, 2024 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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.
Other Names:
  • Rybelsus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (Incidence) of adverse events (AEs)
Time Frame: From baseline (week 0) to 26 weeks
Measured as count of events.
From baseline (week 0) to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: From baseline (week 0) to 26 weeks
Measured in kilogram (kg).
From baseline (week 0) to 26 weeks
Number (Incidence) of hypoglycaemia Level 3 or Level 2
Time Frame: From baseline (week 0) to 26 weeks
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)
Time Frame: From baseline (week 0) to 26 weeks
Measured in percentage (%).
From baseline (week 0) to 26 weeks
Participants achieving HbA1c target <7.0%
Time Frame: At 26 weeks
Measured as count of participants (Yes/No).
At 26 weeks
Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to 26 weeks
Measured in mg/dL.
From baseline (week 0) to 26 weeks
Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)
Time Frame: From baseline (week 0) to 26 weeks
Measured in mg/dL.
From baseline (week 0) to 26 weeks
Dose of Rybelsus
Time Frame: At 26 weeks
Measured in milligrams per day (mg/day).
At 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4652
  • U1111-1243-9500 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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