Diabetes Mellitus, Type 2SURE ITALYNCT04094415
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- How many people
- 581 participants
- Where
- 39 sitesItaly
- Study dates
- 28 Oct 2019to 28 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with type 2 diabetes
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
39 sites in 1 country.
39 sites in 1 country
Italy39 sites
Novo Nordisk Investigational Site
Bagno a Ripoli, 50012
Novo Nordisk Investigational Site
Bari, 70121
Novo Nordisk Investigational Site
Bergamo, 24022
Novo Nordisk Investigational Site
Bergamo, 24030
Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Brindisi, 72100
Novo Nordisk Investigational Site
Casarano (Lecce), 73042
Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Chieri Torino, 10023
Novo Nordisk Investigational Site
Cipolleto Perugia, 06024
Novo Nordisk Investigational Site
Foggia, 71121
Novo Nordisk Investigational Site
Gaeta, 04024
Novo Nordisk Investigational Site
Genova, 16165
Novo Nordisk Investigational Site
L’Aquila, 67051
Novo Nordisk Investigational Site
Livorno, 57124
Novo Nordisk Investigational Site
Milan, 20024
Novo Nordisk Investigational Site
Milan, 20146
Novo Nordisk Investigational Site
Milan, 20162
Novo Nordisk Investigational Site
Naples, 80059
Novo Nordisk Investigational Site
Naples, 80121
Novo Nordisk Investigational Site
Naples, 80126
Novo Nordisk Investigational Site
Naples, 80138
Novo Nordisk Investigational Site
Negrar (VR), 37024
Novo Nordisk Investigational Site
Orbassano, 10043
Novo Nordisk Investigational Site
Pavia, 27100
Novo Nordisk Investigational Site
Prato, 59100
Novo Nordisk Investigational Site
Province of Macerata, 62100
Novo Nordisk Investigational Site
Ravenna, 48121
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Roma, 00186
Novo Nordisk Investigational Site
Rome, 00168
Novo Nordisk Investigational Site
Rozzano (MI), 20089
Novo Nordisk Investigational Site
Sesto San Giovanni (MI), 20099
Novo Nordisk Investigational Site
Treviglio (Bergamo), 24047
Novo Nordisk Investigational Site
Treviso, 31100
Novo Nordisk Investigational Site
Udine, 33100
Novo Nordisk Investigational Site
Vicenza, 36061
Novo Nordisk Investigational Site
Vicenza, 36100
Novo Nordisk Investigational Site
Vigevano, 27100
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)
Measured in % points
Measured: 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
Measured: 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)
Measured in kg
Measured: 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)
Measured in %
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in waist circumference
Measured in cm
Measured: 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)
Number of participants who achieved/not achieved HbA1c level at end of study: below 8.0%
Measured: At end of study (week 28 to 38)
HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: below 7.5%
Measured: At end of study (week 28 to 38)
HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: below 7.0%
Measured: At end of study (week 28 to 38)
Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)
Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Weight reduction of 3.0% or more (yes/no)
Number of participants who achieved/not achieved weight reduction of 3.0% or more
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Weight reduction of 5.0% or more (yes/no)
Number of participants who achieved/not achieved weight reduction of 5.0% or more
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Patient reported severe or documented hypoglycaemia (yes/no)
Number of patients who reported/not reported severe or documented hypoglycaemia
Measured: Between baseline (week 0) and end of study (week 28-38)
Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
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.
Measured: Baseline (week 0), end of study (week 28 to 38)
Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction )
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.
Measured: Baseline (week 0), end of study (week 28 to 38
Change in score for Short Form (SF)-36 v2: Physical summary component
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).
Measured: Baseline (week 0), end of study (week 28 to 38)
Change in score for SF-36 v2: Mental summary component
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).
Measured: Baseline (week 0), end of study (week 28 to 38)
Patient completed the study under treatment with semaglutide (yes/no)
Number of patients who completed/not completed the study under treatment with semaglutide
Measured: At end of study (week 28 to 38)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start28 Oct 2019
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094415
- Sponsor's protocol ID
- NN9535-4549
- Other IDs
- U1111-1233-2023
- Acronym
- SURE ITALY
- Status last verified
- Feb 2023
- First submitted
- 17 Sep 2019
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 36789682
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04094415
- Acronym / sponsor ID
- SURE ITALY / NN9535-4549
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Drug: SemaglutideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with type 2 diabetes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutidePatients 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. | Drug | Semaglutide |
Primary outcome
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)
Measured in % points
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)
Measured in mmol/mol
16 secondary outcomes
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)
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)
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)
HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
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)
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)
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)
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)
Patient reported severe or documented hypoglycaemia (yes/no)
Time frame: Between baseline (week 0) and end of study (week 28-38)
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)
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
Change in score for Short Form (SF)-36 v2: Physical summary component
Time frame: Baseline (week 0), end of study (week 28 to 38)
Change in score for SF-36 v2: Mental summary component
Time frame: Baseline (week 0), end of study (week 28 to 38)
Patient completed the study under treatment with semaglutide (yes/no)
Time frame: At end of study (week 28 to 38)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 36789682Napoli 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.