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NCT Number: NCT06269120

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Siklósi Kórház, Diabetológia

Siklós, 7801, Hungary

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Participants (yes/no).

Secondary outcomes

  1. Change in HbA1c

    Time frame: From Baseline to end of study (week 32)

    Measured in percentage (%)- point.

  2. Change in fasting plasm glucose (FPG)

    Time frame: From Baseline to end of study (week 32)

    Measured in millimoles per liter (mmol/l).

  3. Absolute change in body weight (BW)

    Time frame: From Baseline to end of study (week 32)

    Measured in kilogram (kg).

  4. Relative change in BW

    Time frame: From Baseline to end of study (week 32)

    Measured in %.

  5. HbA1c less than (<) 7.0%

    Time frame: At end of study (week 32)

    Participants (yes/no).

  6. HbA1c <6.5%

    Time frame: At end of study (week 32)

    Participants (yes/no).

  7. Body weight reduction ≥5%

    Time frame: At end of study (week 32)

    Participants (yes/no).

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

    Time frame: From Baseline to end of study (week 32)

    Participants (yes/no).

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

    Time frame: From Baseline to end of study (week 32)

    Participants (yes/no).

  10. Change in waist circumference

    Time frame: From Baseline to end of study (week 32)

    Measured in centimeter (cm).

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

    Time frame: From Baseline to end of study (week 32)

    Measured in millimeter of mercury (mmHg).

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

    Time frame: From Baseline to end of study (week 32)

    Measured in mmol/L.

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

    Time frame: From Baseline to end of study (week 32)

    Measured in milligram per liter (mg/l).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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