RecruitingNot Applicable

SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary

Hungary470 participantsStarted 2024-09-30

Plain-language summary

Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of 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 initiate treatment with commercially available oral semaglutide has been made by the patient/LAR and the treating physician based on local label before and independently from the decision to include the patient in this study. * Male or female, adults above or equal to 18 years of age at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus. * Patient on metformin (Met) with or without modern oral antidiabetic (MOAD, that is Dipeptidyl Peptidase-4 Inhibitor \[DPP4i\] or/and Sodium-glucose cotransporter-2 Inhibitor \[SGLT2i\]) with or without insulin therapy. * Available HbA1c value \> 7.0% within 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice. Exclusion Criteria: * Previous participation in this study (defined as having given informed consent in this study earlier). * Treatment with any investigational drug within 30 days prior to enrolment into the study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the 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

Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%

Timeframe: From Baseline to end of study (week 32)

Trial details

NCT IDNCT06269120

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

View on ClinicalTrials.gov More Type 2 Diabetes trials