NCT04094415|Completed

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

SURE ITALY

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN9535-4549U1111-1233-2023

Study Type

observational

Target

581

Locations

1 country

Sites

Timeline

RegisteredSep 2019

StartedOct 2019

CompletionJul 2021

Brief Summary

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

581

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2019

Geographic Reach

1 country

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

September 17, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed

Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

September 17, 2019

Last Update Submit

February 21, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)
Measured in % points
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)
Measured in mmol/mol
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Secondary Outcomes (16)

Change in body weight (measured in kg)
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in body weight (measured in percent)
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in waist circumference
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)
At end of study (week 28 to 38)
HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
At end of study (week 28 to 38)
+11 more secondary outcomes

Study Arms (1)

Semaglutide

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.

Drug: Semaglutide

Interventions

SemaglutideDRUG

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.

Semaglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participants with type 2 diabetes

You may qualify if:

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
Available and documented haemoglobin A1c (HbA1c) value equal to or less than 12 weeks prior to initiation of semaglutide treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.