Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT04469855
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- semaglutide — DRUGPatients 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.
Study Details
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®.
Key Dates
- Start date
- Jul 27, 2020
- Status verified
- May 2026
- Primary completion
- May 12, 2025
- Completion
- May 12, 2025
Study Design
- Enrollment
- 3,217 participants (actual)
Arms
- Arm: Ozempic®Japanese people with type 2 diabetes being treated in normal clinical practice conditions
Primary Outcome Measure
Number of adverse events (AEs) [ Time Frame: From baseline (day 0) to end of study (month 36) ]
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