A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice (SURE ITALY)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT04094415

U1111-1233-2023 (Other Identifier)

NN9535-4549

Details and patient eligibility

About

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and your diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.

Enrollment: 581 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
• The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
• Male or female, age 18 years or older at the time of signing informed consent
• Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
• Available and documented haemoglobin A1c (HbA1c) value equal to or less than 12 weeks prior to initiation of semaglutide treatment

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
• Treatment with any investigational drug within 90 days prior to enrolment into the study
• Hypersensitivity to semaglutide or to any of the excipients

Trial design

581 participants in 1 patient group

Semaglutide

Description:

Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks.

Treatment:

Drug: Semaglutide