Clinical trial

SURE ITALY: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

Name

NN9535-4549

Description

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.

Trial arms

Trial start

2019-10-28

Estimated PCD

2021-07-28

Trial end

2021-07-28

Status

Completed

Treatment

Semaglutide

Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.

Arms:

Semaglutide

Size

581

Primary endpoint

Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)

Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Change in HbA1c (measured in mmol/mol)

Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 581, 'type': 'ACTUAL'}}

Updated at

2023-02-23

1 organization

Organization

Novo Nordisk