Diabetes Mellitus, Type 2PIONEER REALNCT04878393
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 650 participants
- Where
- 1 siteJapan
- Study dates
- 30 Apr 2021to 9 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Who may be able to join
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- Diagnosed with type 2 diabetes mellitus
- The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
- Male or female, age above or equal to 20 years at the time of signing informed consent
- Available glycated haemoglobin (HbA1c) value greater than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice
- Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Treatment with any investigational drug within 30 days prior to enrolment into the study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters and Safety Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Japan
The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor.
The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral 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.
Oral semaglutideDrug
Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment Receives: Drug: Oral semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
percent-points
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of adverse event (AEs)
Count
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Secondary outcomes (8)
Relative change in body weight
percent
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Absolute change in body weight
Kilogram (Kg)
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
HbA1c less than 7 percent (Yes/No)
Percentage of patients achieving or not achieving the target value
Measured: End of Study visit (Visit 3) (week 34-44)
HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No)
Percentage of patients achieving or not achieving the target value
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)
Percentage of patients achieving or not achieving the target value
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of adverse reactions (ARs)
Count
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of serious adverse events (SAEs)
Count
Measured: From baseline (week 0) to End of Study visit (Visit3) (week 34-44)
Number of serious adverse reactions (SARs)
Count
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start30 Apr 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878393
- Sponsor's protocol ID
- NN9924-4613
- Other IDs
- U1111-1247-5339
- Acronym
- PIONEER REAL
- Status last verified
- Sep 2025
- First submitted
- 5 May 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Suzuki R, Amadid H, Major-Pedersen A, Yabe D. PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan. J Diabetes Investig. 2024 Aug;15(8):1047-1056. doi: 10.1111/jdi.14219. Epub 2024 May 6.
PubMed 38711208
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters and Safety Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Japan
- ClinicalTrials.gov ID
- NCT04878393
- Acronym / sponsor ID
- PIONEER REAL / NN9924-4613
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 7 May 2021 (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 purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor.
The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | Drug: Oral semaglutideAdult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.
Key inclusion criteria (6 listed)
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- Diagnosed with type 2 diabetes mellitus
- The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
- Male or female, age above or equal to 20 years at the time of signing informed consent
- Available glycated haemoglobin (HbA1c) value greater than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice
Key exclusion criteria (3 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Treatment with any investigational drug within 30 days prior to enrolment into the study
- 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 |
|---|---|---|
| Oral semaglutidePatients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study. | Drug | Patients with type 2 diabetes |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
percent-points
Number of adverse event (AEs)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Count
8 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Absolute change in body weight
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
HbA1c less than 7 percent (Yes/No)
Time frame: End of Study visit (Visit 3) (week 34-44)
HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 5 percent (Yes/No)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
HbA1c reduction greater than or equal to 1 percent-points and body weight reduction of greater than or equal to 3 percent (Yes/No)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of adverse reactions (ARs)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of serious adverse events (SAEs)
Time frame: From baseline (week 0) to End of Study visit (Visit3) (week 34-44)
Number of serious adverse reactions (SARs)
Time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Results publication: PubMed 38711208Suzuki R, Amadid H, Major-Pedersen A, Yabe D. PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan. J Diabetes Investig. 2024 Aug;15(8):1047-1056. doi: 10.1111/jdi.14219. Epub 2024 May 6.
- 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. This study is not recruiting at the moment.
Clinical Transparency dept. 1452 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878393, which also lists 1 linked publication.
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 24 Sep 2025.