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Recruiting 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

— Observational Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Semaglutide.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • Change in HbA1c [Time frame: From Baseline to end of study (week 32)]
  • Change in fasting plasm glucose (FPG) [Time frame: From Baseline to end of study (week 32)]
  • Absolute change in body weight (BW) [Time frame: From Baseline to end of study (week 32)]
  • Relative change in BW [Time frame: From Baseline to end of study (week 32)]
  • HbA1c less than (<) 7.0% [Time frame: At end of study (week 32)]
  • HbA1c <6.5% [Time frame: At end of study (week 32)]
  • Body weight reduction ≥5% [Time frame: At end of study (week 32)]
  • HbA1c reduction ≥1%-point and BW reduction ≥5% [Time frame: From Baseline to end of study (week 32)]
  • HbA1c reduction ≥1%-point and BW reduction ≥3% [Time frame: From Baseline to end of study (week 32)]
  • Change in waist circumference [Time frame: From Baseline to end of study (week 32)]
  • Change in blood pressure (BP) (systolic and diastolic) [Time frame: 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]) [Time frame: From Baseline to end of study (week 32)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hungary · 1 center
  • Siklósi Kórház, Diabetológia — Siklós

Identifiers

NCT: NCT06269120 · NN9924-7787 · U1111-1290-8109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗