NCT04469855

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,217 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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®.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	semaglutide	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.

Timeline

• Start date: 2020-07-27
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2020-07-14
• Last updated: 2025-12-31

Locations

414 sites across 1 country: Japan