Clinical trial NCT04094415: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes

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.


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

Primary outcomes:
measure: Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in HbA1c (measured in mmol/mol)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Secondary outcomes:
measure: Change in body weight (measured in kg)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in body weight (measured in percent)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in waist circumference
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Weight reduction of 5.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Patient reported severe or documented hypoglycaemia (yes/no)
timeFrame: Between baseline (week 0) and end of study (week 28-38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction )
timeFrame: Baseline (week 0), end of study (week 28 to 38
measure: Change in score for Short Form (SF)-36 v2: Physical summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for SF-36 v2: Mental summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Patient completed the study under treatment with semaglutide (yes/no)
timeFrame: At end of study (week 28 to 38)
Other outcomes:
Locations:
city: Aquila
country: Italy
facility: Novo Nordisk Investigational Site
city: Bagno a Ripoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Bari
country: Italy
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Brindisi
country: Italy
facility: Novo Nordisk Investigational Site
city: Casarano (Lecce)
country: Italy
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Chieri Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Cipolleto Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: Foggia
country: Italy
facility: Novo Nordisk Investigational Site
city: Gaeta
country: Italy
facility: Novo Nordisk Investigational Site
city: Genova
country: Italy
facility: Novo Nordisk Investigational Site
city: Livorno
country: Italy
facility: Novo Nordisk Investigational Site
city: Macerata
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Negrar (VR)
country: Italy
facility: Novo Nordisk Investigational Site
city: Orbassano
country: Italy
facility: Novo Nordisk Investigational Site
city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Prato
country: Italy
facility: Novo Nordisk Investigational Site
city: Ravenna
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Rozzano (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Sesto San Giovanni (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Treviglio (Bergamo)
country: Italy
facility: Novo Nordisk Investigational Site
city: Treviso
country: Italy
facility: Novo Nordisk Investigational Site
city: Udine
country: Italy
facility: Novo Nordisk Investigational Site
city: Vicenza
country: Italy
facility: Novo Nordisk Investigational Site
city: Vicenza
country: Italy
facility: Novo Nordisk Investigational Site
city: Vigevano
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Napoli R, Berra C, Catarig AM, Di Loreto C, Donatiello E, Berentzen TL, Pitocco D, Giorgino F. Once-weekly semaglutide use in patients with type 2 diabetes: Real-world data from the SURE Italy observational study. Diabetes Obes Metab. 2023 Jun;25(6):1658-1667. doi: 10.1111/dom.15020. Epub 2023 Mar 12.