Diabetes Mellitus, Type 2PIONEER REALNCT04862923
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in the United Kingdom, as Part of Local Clinical Practice
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United Kingdom.
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. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 336 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2021to 31 Aug 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with type 2 diabetes who are 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 18 years at the time of signing informed consent
- Available glycated haemoglobin (HbA1c) value less 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 14 days or less.
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.
United Kingdom1 site
Master Centre for United Kingdom
Gatwick, West Sussex, RH6 0PA
About this study
Official title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in the United Kingdom
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. Participants will get Rybelsus® as prescribed 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. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits 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 treat the participant with a given product is independent of the decision to include him/her in the 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)
Secondary outcomes (7)
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 reduction
Measured: End of Study visit (Visit 3) (week 34-44)
HbA1c reduction greater than or equal to 1 percent-points and body weight reduction greater than or equal to 5 percent (Yes/No)
percentage of patients achieving or not achieving the reduction
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 reduction
Measured: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction
The change version (DTSQc) has the same 8 items as the status version but is reworded to direct the patients to rate their change in treatment satisfaction compared to before being treated with oral semaglutide. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.
Measured: End of Study visit (Visit 3) (week 34-44)
Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction
The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.
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 posted28 Apr 2021
- Study start12 May 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 336 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
- NCT04862923
- Sponsor's protocol ID
- NN9924-4539
- Other IDs
- U1111-1240-3705
- Acronym
- PIONEER REAL
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 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
Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.
PubMed 39316289Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.
PubMed 39535683
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 Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in the United Kingdom
- ClinicalTrials.gov ID
- NCT04862923
- Acronym / sponsor ID
- PIONEER REAL / NN9924-4539
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Apr 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. Participants will get Rybelsus® as prescribed 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. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits 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
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 2 diabetes who are 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 18 years at the time of signing informed consent
- Available glycated haemoglobin (HbA1c) value less 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 treat the participant with a given product is independent of the decision to include him/her in the 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
7 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 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)
Diabetes Treatment Satisfaction Questionnaire, change (DTSQc), relative treatment satisfaction
Time frame: End of Study visit (Visit 3) (week 34-44)
Diabetes Treatment Satisfaction Questionnaire, status (DTSQs), change in absolute treatment satisfaction
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 39316289Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.
- Derived from this study: PubMed 39535683Rudofsky G, Amadid H, Braae UC, Catrina SB, Kick A, Mandavya K, Roslind K, Saravanan P, van Houtum W, Jain AB. Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies. Diabetes Ther. 2025 Jan;16(1):73-87. doi: 10.1007/s13300-024-01668-6. Epub 2024 Nov 13.
- 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 United Kingdom.
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 United Kingdom. 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)). 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 NCT04862923, which also lists 2 linked publications.
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.