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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Oral Semaglutide

• Study Type: Observational
• Enrollment (Estimated): 470

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Hungary
  • Siklós, Hungary, 7801
    • Recruiting
    • Siklósi Kórház, Diabetológia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participant diagnosed with T2D and without any prior or current use of oral semaglutide.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 2 diabetes; 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.	Drug: Oral Semaglutide; Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%	Participants (yes/no).	From Baseline to end of study (week 32)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Measured in percentage (%)- point.	From Baseline to end of study (week 32)
Change in fasting plasm glucose (FPG)	Measured in millimoles per liter (mmol/l).	From Baseline to end of study (week 32)
Absolute change in body weight (BW)	Measured in kilogram (kg).	From Baseline to end of study (week 32)
Relative change in BW	Measured in %.	From Baseline to end of study (week 32)
HbA1c less than (<) 7.0%	Participants (yes/no).	At end of study (week 32)
HbA1c <6.5%	Participants (yes/no).	At end of study (week 32)
Body weight reduction ≥5%	Participants (yes/no).	At end of study (week 32)
HbA1c reduction ≥1%-point and BW reduction ≥5%	Participants (yes/no).	From Baseline to end of study (week 32)
HbA1c reduction ≥1%-point and BW reduction ≥3%	Participants (yes/no).	From Baseline to end of study (week 32)
Change in waist circumference	Measured in centimeter (cm).	From Baseline to end of study (week 32)
Change in blood pressure (BP) (systolic and diastolic)	Measured in millimeter of mercury (mmHg).	From Baseline to end of study (week 32)
Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])	Measured in mmol/L.	From Baseline to end of study (week 32)
Change in high sensitive C-reactive protein (hsCRP)	Measured in milligram per liter (mg/l).	From Baseline to end of study (week 32)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9924-7787; U1111-1290-8109 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No