A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Japan, as Part of Local Clinical Practice (PIONEER REAL)

September 23, 2025 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

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

Study Locations

  • Japan
      • Tokyo, Japan, 1000005
        • Master Centre for Japan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with type 2 diabetes
Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment
Drug: Oral semaglutide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
percent-points
From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Number of adverse event (AEs)
Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
Count
From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)
percent
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)
Kilogram (Kg)
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)
Percentage of patients achieving or not achieving the target value
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)
Percentage of patients achieving or not achieving the target value
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)
Percentage of patients achieving or not achieving the target value
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)
Count
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)
Count
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)
Count
From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

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. 1452, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 30, 2021

Primary Completion (Actual)

February 9, 2023

Study Completion (Actual)

February 9, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4613
  • U1111-1247-5339 (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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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