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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1233-2023 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (measured in kg) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with type 2 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bagno a Ripoli | 50012 | Italy | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36789682 | Background | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
Measured in %
| 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 | 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% | 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% | 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% | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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). | 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). | 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 | At end of study (week 28 to 38) |
| Bari |
| 70121 |
| Italy |
| Novo Nordisk Investigational Site | Bergamo | 24022 | Italy |
| Novo Nordisk Investigational Site | Bergamo | 24030 | Italy |
| Novo Nordisk Investigational Site | Bologna | 40138 | Italy |
| Novo Nordisk Investigational Site | Brindisi | 72100 | Italy |
| Novo Nordisk Investigational Site | Casarano (Lecce) | 73042 | Italy |
| Novo Nordisk Investigational Site | Catanzaro | 88100 | Italy |
| Novo Nordisk Investigational Site | Chieri Torino | 10023 | Italy |
| Novo Nordisk Investigational Site | Cipolleto Perugia | 06024 | Italy |
| Novo Nordisk Investigational Site | Foggia | 71121 | Italy |
| Novo Nordisk Investigational Site | Gaeta | 04024 | Italy |
| Novo Nordisk Investigational Site | Genova | 16165 | Italy |
| Novo Nordisk Investigational Site | Livorno | 57124 | Italy |
| Novo Nordisk Investigational Site | L’Aquila | 67051 | Italy |
| Novo Nordisk Investigational Site | Milan | 20024 | Italy |
| Novo Nordisk Investigational Site | Milan | 20146 | Italy |
| Novo Nordisk Investigational Site | Milan | 20162 | Italy |
| Novo Nordisk Investigational Site | Naples | 80059 | Italy |
| Novo Nordisk Investigational Site | Naples | 80121 | Italy |
| Novo Nordisk Investigational Site | Naples | 80126 | Italy |
| Novo Nordisk Investigational Site | Naples | 80138 | Italy |
| Novo Nordisk Investigational Site | Negrar (VR) | 37024 | Italy |
| Novo Nordisk Investigational Site | Orbassano | 10043 | Italy |
| Novo Nordisk Investigational Site | Pavia | 27100 | Italy |
| Novo Nordisk Investigational Site | Prato | 59100 | Italy |
| Novo Nordisk Investigational Site | Province of Macerata | 62100 | Italy |
| Novo Nordisk Investigational Site | Ravenna | 48121 | Italy |
| Novo Nordisk Investigational Site | Roma | 00161 | Italy |
| Novo Nordisk Investigational Site | Roma | 00186 | Italy |
| Novo Nordisk Investigational Site | Rome | 00168 | Italy |
| Novo Nordisk Investigational Site | Rozzano (MI) | 20089 | Italy |
| Novo Nordisk Investigational Site | Sesto San Giovanni (MI) | 20099 | Italy |
| Novo Nordisk Investigational Site | Treviglio (Bergamo) | 24047 | Italy |
| Novo Nordisk Investigational Site | Treviso | 31100 | Italy |
| Novo Nordisk Investigational Site | Udine | 33100 | Italy |
| Novo Nordisk Investigational Site | Vicenza | 36061 | Italy |
| Novo Nordisk Investigational Site | Vicenza | 36100 | Italy |
| Novo Nordisk Investigational Site | Vigevano | 27100 | Italy |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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