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
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT05755360
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide — DRUGParticipants 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.
Study Details
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.
Key Dates
- Start date
- Feb 21, 2023
- Status verified
- Sep 2025
- Primary completion
- Oct 21, 2024
- Completion
- Oct 21, 2024
Study Design
- Enrollment
- 291 participants (actual)
Arms
- Arm: Participants with T2DParticipants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
Primary Outcome Measure
Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point) [ Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) ]
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