Diabetes Mellitus, Type 2PIONEER REALNCT05502562
A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
Trial summary
The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). 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
- 388 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2023to 3 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with type 2 diabetes and naive 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 (T2D).
- 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 A1c (HbA1c) value less than or equal to (<=) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
- Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to (<=) 14 days.
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Any prior or current use of oral semaglutide.
- Hypersensitivity to oral semaglutide or to any of the excipients.
- Treatment with any investigational drug within 30 days prior to signing of informed consent.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
About this study
Official title: A Multicentre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Initiation of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in India
The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.
- 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
Participants 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 participant in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with type 2 diabetes | Adult participants with type 2 diabetes and naive 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 A1c (HbA1c)
Measured as percentage (%)-points.
Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Secondary outcomes (5)
Relative change in body weight
Measured in percentage (%).
Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Absolute change in body weight
Measured in kilogram (kg).
Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Glycated haemoglobin A1c (HbA1c) less than (<) 7%
Measured as Yes or No.
Measured: At End of Study visit (V3) (week 34-44)
HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 5%
Measured as Yes or No.
Measured: From baseline (week 0) to End of Study visit (V3) (week 34-44)
HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 3%
Measured as Yes or No.
Measured: From baseline (week 0) to End of Study visit (V3) (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 posted16 Aug 2022
- Study start24 Feb 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
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
- 388 participants (actual)
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
- NCT05502562
- Sponsor's protocol ID
- NN9924-4960
- Other IDs
- U1111-1270-0826
- Acronym
- PIONEER REAL
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Publications
Sanyal D, Saboo B, Phatak SR, Kumar PKM, Basu D, Verma N, Nair A, Bhattacharjee K, Aneja P, Makkar BMM, Negalur V, Mithal A, Unnikrishnan AG. Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India. Indian J Endocrinol Metab. 2025 Sep-Oct;29(5):523-530. doi: 10.4103/ijem.ijem_179_25. Epub 2025 Oct 25.
PubMed 41229720
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Initiation of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in India
- ClinicalTrials.gov ID
- NCT05502562
- Acronym / sponsor ID
- PIONEER REAL / NN9924-4960
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 16 Aug 2022 (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 look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with type 2 diabetes | – | Drug: Oral semaglutideAdult participants with type 2 diabetes and naive to injectable glucose-lowering treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with type 2 diabetes and naive 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 (T2D).
- 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 A1c (HbA1c) value less than or equal to (<=) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
Key exclusion criteria (6 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Any prior or current use of oral semaglutide.
- Hypersensitivity to oral semaglutide or to any of the excipients.
- Treatment with any investigational drug within 30 days prior to signing of informed consent.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
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 semaglutideParticipants 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 participant in this study. | Drug | Participants with type 2 diabetes |
Primary outcome
Change in Glycated haemoglobin A1c (HbA1c)
Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Measured as percentage (%)-points.
5 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Absolute change in body weight
Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
Glycated haemoglobin A1c (HbA1c) less than (<) 7%
Time frame: At End of Study visit (V3) (week 34-44)
HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 5%
Time frame: From baseline (week 0) to End of Study visit (V3) (week 34-44)
HbA1c reduction greater than or equal to (>=) 1%-points and body weight reduction of greater than or equal to (>=) 3%
Time frame: From baseline (week 0) to End of Study visit (V3) (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 19 Sep 2024.
- Derived from this study: PubMed 41229720Sanyal D, Saboo B, Phatak SR, Kumar PKM, Basu D, Verma N, Nair A, Bhattacharjee K, Aneja P, Makkar BMM, Negalur V, Mithal A, Unnikrishnan AG. Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India. Indian J Endocrinol Metab. 2025 Sep-Oct;29(5):523-530. doi: 10.4103/ijem.ijem_179_25. Epub 2025 Oct 25.
- 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. 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 6 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
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 A1c (HbA1c) (time frame: From baseline (week 0) to End of Study visit (V3) (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 NCT05502562, 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 19 Sep 2024.