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

Novo Nordisk

Status: Invitation-only

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT04469855

U1111-1187-9072 (Other Identifier)

NN9535-4347

Details and patient eligibility

About

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®.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Ozempic®

Description:

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

Treatment:

Drug: semaglutide