DOORS: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Change From Dipeptidyl Peptidase-4 Inhibitor (DPP4i) Treatment to Oral Semaglutide in Italy
- Registration Number
- NCT05755360
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 390
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- The decision to switch from DPP4i treatment to commercially available oral semaglutide has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study
- Participant with last measurement of HbA1c >= 7.5% at informed consent and treatment initiation visit (V1) or less than or equal to (<=) 90 days before informed consent and treatment initiation visit (V1)
- Treatment naïve to insulin. An exception is short-term insulin treatment for acute illness for a total of < 14 days
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (V1) and throughout the duration of the study
- Participants with type-1 diabetes
- Participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Age < 18 years on the informed consent and treatment initiation visit (V1)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with T2D Semaglutide Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
- Primary Outcome Measures
Name Time Method Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol]) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in mmol/mol.
Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in %-point.
- Secondary Outcome Measures
Name Time Method Absolute change in waist circumference From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in centimeters (cm).
Absolute change in blood pressure (systolic and diastolic) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in millimeters of mercury (mmHg).
Number of participants with HbA1c <6.5% At end of study (week 40 ± 4 weeks) Measured as number of participants (yes or no).
Absolute change in body weight From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in Kilograms (kg).
HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3% From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured as number of participants (yes or no).
Relative change in body weight From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in percentage (%).
Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured in millimoles per liter (mmol/L).
Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) 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.
HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5% From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured as number of participants (yes or no).
Self-reported severe hypoglycaemia during the study period From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) Measured as number of participants (yes or no).
Absolute change in diabetes distress survey (DDS) scores (points) From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) 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.
Number of participants with HbA1c less than (<) 7% At end of study (week 40 ± 4 weeks) Measured as number of participants (yes or no).
Trial Locations
- Locations (25)
A.O.U. Policlinico S.Orsola
🇮🇹Bologna, Italy
A.O.U. Maggiore della Carità
🇮🇹Piemonte, Italy
P.O. Praia a Mare
🇮🇹Praia a Mare, Italy
ASL Caserta
🇮🇹Caserta, Italy
Ospedale Misericordia
🇮🇹Grosseto, Italy
ASL Cuneo 1
🇮🇹Cuneo, Italy
INRCA
🇮🇹Ancona, Italy
Ospedale Pesenti Fenaroli
🇮🇹Alzano Lombardo, Italy
Ospedale centrale L. Bohler
🇮🇹Bolzano, Italy
Azienda Ospedaliera Cannizzaro
🇮🇹Catania, Italy
Università degli Studi Foggia
🇮🇹Foggia, Italy
Ospedale Pagliari
🇮🇹Massafra, Italy
ASL Lecce
🇮🇹Nardò, Italy
Ospedale Generale provinciale
🇮🇹Macerata, Italy
ASL Avellino
🇮🇹Montoro, Italy
Casa di cure Triolo Zancla
🇮🇹Sicilia, Italy
Ospedale Treviglio
🇮🇹Treviglio, Italy
Fondazione Univ. Policlinico A.Gemelli
🇮🇹Roma, Italy
ASL Napoli 3 sud
🇮🇹Palma Campania, Italy
Ospedale San Jacopo
🇮🇹Pistoia, Italy
Casa della Salute ASL RM2
🇮🇹Roma, Italy
A.O.U. Policlinico Giaccone
🇮🇹Sicilia, Italy
Ospedale Santo Spirito
🇮🇹Roma, Italy
Ospedale S. Maria della Misericordia
🇮🇹Udine, Italy
ASST Sette Laghi
🇮🇹Varese, Italy