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

NCT06269120 | Recruiting

• 2 other identifiers: NN9924-7787U1111-1290-8109
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in HbA1c

  From Baseline to end of study (week 32)

• Change in fasting plasm glucose (FPG)

  From Baseline to end of study (week 32)

• Absolute change in body weight (BW)

  From Baseline to end of study (week 32)

• Relative change in BW

  From Baseline to end of study (week 32)

• HbA1c less than (<) 7.0%

  At end of study (week 32)

Study Arms (1)

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

Interventions

Oral Semaglutide DRUG

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.

Patients with type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Siklósi Kórház, Diabetológia

Siklós, 7801, Hungary

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: September 30, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

HU (1)