Understanding the effects of oral semaglutide on diabetes management in Hungary

SEMA-CardioDiab HUNGARY: A Multicentre, Prospective, Non-interventional Study to Evaluate Glycemic Control and Weight Changes in Patients With Type 2 Diabetes Initiating Treatment With Oral Semaglutide by Cardiologists or Diabetologists as Part of Local Clinical Practice in Hungary

This study is testing how well oral semaglutide helps people with type 2 diabetes in Hungary manage their blood sugar, lose weight, and reduce heart risks over about six months.

Quick facts

• Study type: Observational
• Enrollment: 470 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Siklós)
• Trial ID: NCT06269120 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the effects of oral semaglutide on blood sugar levels, weight, and cardiovascular risk in individuals with type 2 diabetes in Hungary. Participants will receive oral semaglutide as prescribed by their doctor and will be monitored over a period of approximately 26 weeks. They will complete questionnaires regarding their medication adherence and overall health during regular doctor visits, which will also include lab tests. The study aims to gather real-world data on the treatment's effectiveness and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with type 2 diabetes and are currently on metformin with or without additional diabetes medications.

Not a fit: Patients who are not on metformin or those with type 1 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of oral semaglutide for managing type 2 diabetes and improving patient outcomes.

How similar studies have performed: Other studies have shown positive outcomes with similar approaches using semaglutide for diabetes management, indicating a promising avenue for further exploration.

Eligibility criteria

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).
* Patients diagnosed with type 1 diabetes mellitus.
* Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration.

Where this trial is running

Siklós

• Siklósi Kórház, Diabetológia — Siklós, Hungary (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Type 2 Diabetes