GLP-1 Peptide Atlas, by Delfa

Recruiting

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

470

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point (HbA1c, change, ≥5% weight-loss responders)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06269120

Org study IDNN9924-7787

Secondary IDU1111-1290-8109World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-02-21actual

Study start2024-09-30actual

Last update posted2025-12-05actual

Primary completion2026-03-31estimated

Study completion2026-03-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Absolute change in body weight (BW)

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative change in BW

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body weight reduction ≥5%

Time frame:At end of study (week 32)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

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)

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint

Change in HbA1c

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasm glucose (FPG)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c less than (<) 7.0%

Time frame:At end of study (week 32)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <6.5%

Time frame:At end of study (week 32)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

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

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

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

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

Change in high sensitive C-reactive protein (hsCRP)

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

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other (unclassified)

1 endpoint

Secondary/protocol endpoint

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

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

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.