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

Novo Nordisk

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Drug: Oral Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT06269120

U1111-1290-8109 (Other Identifier)

NN9924-7787

Details and patient eligibility

About

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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

470 participants in 1 patient group

Patients with type 2 diabetes

Description:

Participants with Type 2 Diabetes (T2D) will initiate oral semaglutide at the discretion of the treating physician, based on approved oral semaglutide label in Hungary and independent from the decision to include the patient in the study.

Treatment:

Drug: Oral Semaglutide