PIONEER REAL

Completed

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

650

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•HbA1c, change•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04878393

Org study IDNN9924-4613

Secondary IDU1111-1247-5339World Health Organization (WHO)

Timeline

Milestones

Study start2021-04-30actual

Study first posted2021-05-07actual

Primary completion2023-02-09actual

Study completion2023-02-09actual

Last update posted2025-09-24actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll

Sampling methodNon probability sample

Study population text

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

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c less than 7 percent (Yes/No)

Time frame:End of Study visit (Visit 3) (week 34-44)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of adverse event (AEs)

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of adverse reactions (ARs)

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of serious adverse events (SAEs)

Time frame:From baseline (week 0) to End of Study visit (Visit3) (week 34-44)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of serious adverse reactions (SARs)

Time frame:From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)

Serious AEs (any)

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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)

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice (PIONEER REAL Japan): Subgroup analyses.
Journal of diabetes investigation2025 Oct (month)PMID40711887doi:10.1111/jdi.70099via pubmed nct search
PIONEER REAL Japan: Primary results from a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice.
Journal of diabetes investigation2024 Nov (month)PMID39172634doi:10.1111/jdi.14291via pubmed nct search
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.
Journal of diabetes investigation2024 Aug (month)PMID38711208doi:10.1111/jdi.14219via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.