CompletedNot Applicable

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

Italy291 participantsStarted 2023-02-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point)

Timeframe: 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])

Timeframe: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

Trial details

NCT IDNCT05755360

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-10-21

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point)

Timeframe: 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])

Timeframe: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)