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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1274-4674 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from DPP4i to oral semaglutide. Participant will get oral semaglutide as prescribed by the study doctor. The study will last for about 5-6 months. Participants will be asked to complete two questionnaires. One will be about eating behaviour and the other one will be diabetes related. Participant will complete this questionnaire during the normal scheduled visit with study doctor. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with T2D | Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician. The decision to switch from DPP4i treatment to oral semaglutide is at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point) | Measured in %-point. | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol]) | Measured in mmol/mol. | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in percentage (%). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in body weight | Measured in Kilograms (kg). |
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Inclusion Criteria:
Exclusion Criteria:
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All Participants who switch from DPP4i treatment to oral semaglutide and meet the eligibility criteria will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Pesenti Fenaroli | Alzano Lombardo | 24022 | Italy | |||
| INRCA |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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|
| From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides) | Measured in millimoles per liter (mmol/L). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in waist circumference | Measured in centimeters (cm). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in blood pressure (systolic and diastolic) | Measured in millimeters of mercury (mmHg). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Number of participants with HbA1c less than (<) 7% | Measured as number of participants (yes or no). | At end of study (week 40 ± 4 weeks) |
| Number of participants with HbA1c <6.5% | Measured as number of participants (yes or no). | At end of study (week 40 ± 4 weeks) |
| HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5% | Measured as number of participants (yes or no). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3% | Measured as number of participants (yes or no). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Self-reported severe hypoglycaemia during the study period | Measured as number of participants (yes or no). | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points) | DEBQ is a 33-item self-reported questionnaire to assess three distinct eating behaviours in adults: emotional eating, external eating, and restrained eating. For all 33 items participants will provide response in terms of: never, seldom, sometimes, often, very often. Absolute change in DEBQ (total score) calculated as the absolute difference between the DEBQ scores (total score) at baseline and post baseline measurements of DEBQ scores (total score) up to and including end of study visit. | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Absolute change in diabetes distress survey (DDS) scores (points) | DDS is a self-administered 17-item scale that captures four critical dimensions of diabetes-related distress: emotional burden, regimen distress, interpersonal distress, and physician distress. Each item was scored in the range of 1 to 6: 1) not a problem; 2) a slight problem; 3) a moderate problem; 4) somewhat serious problem; 5) a serious problem; 6) a very serious problem. Participants will rate each item item indicating the degree to which each of the 17 items may have distressed or bothered them during the past month. High score indicated high distress. | From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) |
| Ancona |
| 60127 |
| Italy |
| A.O.U. Policlinico S.Orsola | Bologna | 40138 | Italy |
| Ospedale centrale L. Bohler | Bolzano | 39100 | Italy |
| ASL Caserta | Caserta | 81100 | Italy |
| Azienda Ospedaliera Cannizzaro | Catania | 95126 | Italy |
| Azienda Sanitaria Locale Cn1 | Cuneo | 12100 | Italy |
| Università degli Studi Foggia | Foggia | 71122 | Italy |
| Ospedale Misericordia | Grosseto | 58100 | Italy |
| ASL Lecce | Lecce | 73100 | Italy |
| Ospedale Pagliari | Massafra | 74016 | Italy |
| ASL Avellino | Montoro | 83026 | Italy |
| ASL Napoli 3 sud | Palma Campania | 80036 | Italy |
| A.O.U. Maggiore della Carità | Piemonte | 28100 | Italy |
| Ospedale San Jacopo | Pistoia | 51100 | Italy |
| P.O. Praia a Mare | Praia a Mare | 87028 | Italy |
| Ospedale Generale provinciale | Province of Macerata | 62100 | Italy |
| ASL Roma 2 - UOC Cure Primarie Distretto 4 | Roma | 00159 | Italy |
| Fondazione Univ. Policlinico A.Gemelli | Roma | 00168 | Italy |
| ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia | Roma | 00195 | Italy |
| A.O.U. Policlinico Giaccone | Sicilia | 90127 | Italy |
| Casa di cure Triolo Zancla | Sicilia | 90133 | Italy |
| Ospedale Treviglio | Treviglio | 24047 | Italy |
| Ospedale S. Maria della Misericordia | Udine | 33100 | Italy |
| ASST Sette Laghi | Varese | 21100 | 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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