Post-Marketing Surveillance (Special Use-results Surveill... | NCT04469855

ID	Type	Description	Link
U1111-1187-9072	Other Identifier	World Health Organization (WHO)

Official Title

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

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2020Actual

Primary Completion Date

May 12, 2025Actual

Completion Date

May 12, 2025Actual

First Submitted Date

Jul 10, 2020

First Submission Date that Met QC Criteria

Jul 10, 2020

First Posted Date

Jul 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,217Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ozempic®		Japanese people with type 2 diabetes being treated in normal clinical practice conditions	Drug: semaglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events (AEs)	Count	From baseline (day 0) to end of study (month 36)

Secondary Outcomes

Measure	Description	Time Frame
Number of serious adverse reactions (SARs)	Count	From baseline (day 0) to end of study (month 36)
Number of adverse reactions (ARs)	Count

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seino Internal Medicine Clinic_Internal medicine		Koriyama-shi, Fukushima	Fukushima, Japan	963-8851	Japan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://novonordisk-trials.com

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases