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Type 2 DiabetesNCT06269120

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

An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 19 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Oral Semaglutide
Type of treatment
Pill or oral medicine
How many people
243 participants
Where
19 sitesHungary
Study dates
30 Sep 2024to 5 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

19 sites in 1 country.

19 sites in 1 country

Hungary19 sites

  • Békés Vármegyei Központi Kórház

    Békéscsaba, 5600

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106

  • Semmelweis Egyetem, Általános Orvostudományi Kar Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122

  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Diabetológia Szakrendelés

    Budapest, 1135

  • Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Diabetológia

    Budapest, 1204

  • Debreceni Egyetem Belgyógyászati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • DE KK Kardiológiai és Szívsebészeti klinika

    Debrecen, 4032

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet, Kardiológiai Osztály

    Eger, 3300

  • Háziorvosi Rendelő

    Felsőrajk, 8767

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Békés Vármegyei Központi Kórház

    Gyula, Bekes County, 5700

  • Bács-Kiskun Vármegyei Oktatókórház Invazív Kardiológiai Osztály

    Kecskemét, 6000

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház

    Miskolc, 3526

  • Jósa András Oktatókórház

    Nyíregyháza, 4400

  • Coromed SMO Kft.

    Pécs, 7623

  • Pécsi Tudományegyetem Általános Orvostudományi Kar Klinikai Központ II.sz. Belgyógyászati Klinika és Nephrológiai Centrum

    Pécs, H-7623

  • Siklósi Kórház, Diabetológia

    Siklós, 7801

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, 6725

Other trials in Hungary

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
Oral Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral SemaglutideDrug

    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.

Study groups in NCT06269120
Study groupRoleWhat they receive
Patients with type 2 diabetesParticipants 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.
Receives: Drug: Oral Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Participants (yes/no).

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

Secondary outcomes (13)

  1. Change in HbA1c

    Measured in percentage (%)- point.

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

  2. Change in fasting plasm glucose (FPG)

    Measured in millimoles per liter (mmol/l).

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

  3. Absolute change in body weight (BW)

    Measured in kilogram (kg).

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

  4. Relative change in BW

    Measured in %.

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

  5. HbA1c less than (<) 7.0%

    Participants (yes/no).

    Measured: At end of study (week 32)

  6. HbA1c <6.5%

    Participants (yes/no).

    Measured: At end of study (week 32)

  7. Body weight reduction ≥5%

    Participants (yes/no).

    Measured: At end of study (week 32)

  8. HbA1c reduction ≥1%-point and BW reduction ≥5%

    Participants (yes/no).

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

  9. HbA1c reduction ≥1%-point and BW reduction ≥3%

    Participants (yes/no).

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

  10. Change in waist circumference

    Measured in centimeter (cm).

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

  11. Change in blood pressure (BP) (systolic and diastolic)

    Measured in millimeter of mercury (mmHg).

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

  12. Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])

    Measured in mmol/L.

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

  13. Change in high sensitive C-reactive protein (hsCRP)

    Measured in milligram per liter (mg/l).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start30 Sep 2024
  3. Primary completion5 May 2026
  4. Study completion5 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06269120
Sponsor's protocol ID
NN9924-7787
Other IDs
U1111-1290-8109
Status last verified
Aug 2026
First submitted
13 Feb 2024
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 19 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% (time frame: From Baseline to end of study (week 32)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06269120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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