Diabetes Mellitus, Type 2NCT05714683
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
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2027to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Adult, Older adult
Study population: Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Rybelsus
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (Incidence) of adverse events (AEs)
Measured as count of events.
Measured: From baseline (week 0) to 26 weeks
Secondary outcomes (7)
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.
Measured: From baseline (week 0) to 26 weeks
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%).
Measured: From baseline (week 0) to 26 weeks
Participants achieving HbA1c target <7.0%
Measured as count of participants (Yes/No).
Measured: At 26 weeks
Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)
Measured in mg/dL.
Measured: From baseline (week 0) to 26 weeks
Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)
Measured in mg/dL.
Measured: From baseline (week 0) to 26 weeks
Change in body weight
Measured in kilogram (kg).
Measured: From baseline (week 0) to 26 weeks
Dose of Rybelsus
Measured in milligrams per day (mg/day).
Measured: At 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start31 Jan 2027 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714683
- Sponsor's protocol ID
- NN9924-4652
- Other IDs
- U1111-1243-9500
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05714683
- Acronym / sponsor ID
- NN9924-4652
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with T2DM | – | Drug: SemaglutideAll 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: RybelsusAll 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. | Drug | Participants with T2DM |
Primary outcome
Number (Incidence) of adverse events (AEs)
Time frame: From baseline (week 0) to 26 weeks
Measured as count of events.
7 secondary outcomes
Number (Incidence) of hypoglycaemia Level 3 or Level 2
Time frame: From baseline (week 0) to 26 weeks
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to 26 weeks
Participants achieving HbA1c target <7.0%
Time frame: At 26 weeks
Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)
Time frame: 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
Change in body weight
Time frame: From baseline (week 0) to 26 weeks
Dose of Rybelsus
Time frame: At 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (Incidence) of adverse events (AEs) (time frame: From baseline (week 0) to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.