GLP-1 Peptide Atlas, by Delfa

Completed

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

414

Recruiting sites

—

Enrollment

3,217

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•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 IDNCT04469855

Org study IDNN9535-4347

Secondary IDU1111-1187-9072World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-07-14actual

Study start2020-07-27actual

Primary completion2025-05-12actual

Study completion2025-05-12actual

Last update posted2026-05-19actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Japanese people with type 2 diabetes being treated in normal clinical practice conditions

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).

•The decision to initiate treatment with commercially available Ozempic® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

•Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®.

•Male or female, no age limitation.

Exclusion criteria

•Previous participation in this study. Participation is defined as having given informed consent in this study.

•Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

•Patients who fall under contraindications to the label.

•Patients who are or have previously been treated with Ozempic®.

•Female who is pregnant, breast-feeding or intends to become pregnant.

Endpoints (12)

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

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (day 0) to end of study (month 36)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in glycosylated haemoglobin A1c (HbA1c)

Time frame:From baseline (day 0) to end of study (month 36)

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (day 0) to end of study (month 36)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score

Time frame:From baseline (day 0) to visit 5 (month 12)

change from baseline, improvement

Secondary/protocol endpoint

Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities

Time frame:From baseline (day 0) to visit 5 (month 12)

change from baseline, improvement

Secondary/protocol endpoint

Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment

Time frame:From baseline (day 0) to visit 5 (month 12)

change from baseline, improvement

Secondary/protocol endpoint

Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia

Time frame:From baseline (day 0) to visit 5 (month 12)

change from baseline, improvement

Secondary/protocol endpoint

Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment

Time frame:From baseline (day 0) to visit 5 (month 12)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of adverse events (AEs)

Time frame:From baseline (day 0) to end of study (month 36)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of serious adverse reactions (SARs)

Time frame:From baseline (day 0) to end of study (month 36)

event count, event

Secondary/protocol endpoint

Number of adverse reactions (ARs)

Time frame:From baseline (day 0) to end of study (month 36)

event count, event

Secondary/protocol endpoint

Number of serious adverse events (SAEs)

Time frame:From baseline (day 0) to end of study (month 36)

Serious AEs (any)

event count, event

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.