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

Diabetes Mellitus, Type 2 Clinical Trial

— DOORS  

Official title:

A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05755360
• Other study ID #: NN9924-7508
• Secondary ID: U1111-1274-4674
• Status: Active, not recruiting
• Start date: February 21, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
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.

Locations

Country	Name	City	State
Italy	Ospedale Pesenti Fenaroli	Alzano Lombardo
Italy	INRCA	Ancona
Italy	A.O.U. Policlinico S.Orsola	Bologna
Italy	Ospedale centrale L. Bohler	Bolzano
Italy	ASL Caserta	Caserta
Italy	Azienda Ospedaliera Cannizzaro	Catania
Italy	ASL Cuneo 1	Cuneo
Italy	Università degli Studi Foggia	Foggia
Italy	Ospedale Misericordia	Grosseto
Italy	Ospedale Generale provinciale	Macerata
Italy	Ospedale Pagliari	Massafra
Italy	ASL Avellino	Montoro
Italy	ASL Lecce	Nardò
Italy	ASL Napoli 3 sud	Palma Campania
Italy	A.O.U. Maggiore della Carità	Piemonte
Italy	Ospedale San Jacopo	Pistoia
Italy	P.O. Praia a Mare	Praia a Mare
Italy	Casa della Salute ASL RM2	Roma
Italy	Fondazione Univ. Policlinico A.Gemelli	Roma
Italy	Ospedale Santo Spirito	Roma
Italy	A.O.U. Policlinico Giaccone	Sicilia
Italy	Casa di cure Triolo Zancla	Sicilia
Italy	Ospedale Treviglio	Treviglio
Italy	Ospedale S. Maria della Misericordia	Udine
Italy	ASST Sette Laghi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	Relative change in body weight	Measured in percentage (%).	From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Secondary	Absolute change in body weight	Measured in Kilograms (kg).	From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of participants with HbA1c less than (<) 7%	Measured as number of participants (yes or no).	At end of study (week 40 ± 4 weeks)
Secondary	Number of participants with HbA1c <6.5%	Measured as number of participants (yes or no).	At end of study (week 40 ± 4 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)