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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name SURE ITALY

NCTNCT04094415 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4549Other idU1111-1233-2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
581 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
1 country

Italy

Start
28 Oct 2019
Primary completion
28 Jul 2021
Completion
28 Jul 2021
First posted
19 Sept 2019
Last update posted
23 Feb 2023
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph –

    SURE ITALY

    NCT04094415

    28 Oct 2019 to 28 Jul 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug

Arms1

  • Other

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

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

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

    Registry description

    Measured in % points

  2. Change in HbA1c (measured in mmol/mol)

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

    Registry description

    Measured in mmol/mol

Secondary outcomes(16)

  1. Change in body weight (measured in kg)

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

    Registry description

    Measured in kg

  2. Change in body weight (measured in percent)

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

    Registry description

    Measured in %

  3. Change in waist circumference

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

    Registry description

    Measured in cm

  4. HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)

    Time frame · At end of study (week 28 to 38)

    Registry description

    Number of participants who achieved/not achieved HbA1c level at end of study: below 8.0%

  5. HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)

    Time frame · At end of study (week 28 to 38)

    Registry description

    Number of participants who achieved/not achieved HbA1c level at end of study: below 7.5%

  6. HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)

    Time frame · At end of study (week 28 to 38)

    Registry description

    Number of participants who achieved/not achieved HbA1c level at end of study: below 7.0%

  7. Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)

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

    Registry description

    Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more

  8. Weight reduction of 3.0% or more (yes/no)

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

    Registry description

    Number of participants who achieved/not achieved weight reduction of 3.0% or more

  9. Weight reduction of 5.0% or more (yes/no)

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

    Registry description

    Number of participants who achieved/not achieved weight reduction of 5.0% or more

  10. HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)

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

    Registry description

    Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more

  11. Patient reported severe or documented hypoglycaemia (yes/no)

    Time frame · Between baseline (week 0) and end of study (week 28-38)

    Registry description

    Number of patients who reported/not reported severe or documented hypoglycaemia

  12. Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction

    Time frame · Baseline (week 0), end of study (week 28 to 38)

    Registry description

    The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.

  13. Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction )

    Time frame · Baseline (week 0), end of study (week 28 to 38

    Registry description

    The change version (DTSQc) has the same 8 items as the status version, but is reworded to direct the patients to compare the experience of the current treatment with the experience of previous treatment. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.

  14. Change in score for Short Form (SF)-36 v2: Physical summary component

    Time frame · Baseline (week 0), end of study (week 28 to 38)

    Registry description

    The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).

  15. Change in score for SF-36 v2: Mental summary component

    Time frame · Baseline (week 0), end of study (week 28 to 38)

    Registry description

    The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).

  16. Patient completed the study under treatment with semaglutide (yes/no)

    Time frame · At end of study (week 28 to 38)

    Registry description

    Number of patients who completed/not completed the study under treatment with semaglutide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2023

8 results

Once-weekly semaglutide use in patients with type 2 diabetes: Real-world data from the SURE Italy observational study.

Napoli et al. 2023Diabetes, obesity & metabolismcited by 26

PMID 36789682DOI 10.1111/dom.15020PUB-36789682

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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