Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06269120
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Participants (yes/no).'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in percentage (%)- point.'}, {'measure': 'Change in fasting plasm glucose (FPG)', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in millimoles per liter (mmol/l).'}, {'measure': 'Absolute change in body weight (BW)', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in kilogram (kg).'}, {'measure': 'Relative change in BW', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in %.'}, {'measure': 'HbA1c less than (<) 7.0%', 'timeFrame': 'At end of study (week 32)', 'description': 'Participants (yes/no).'}, {'measure': 'HbA1c <6.5%', 'timeFrame': 'At end of study (week 32)', 'description': 'Participants (yes/no).'}, {'measure': 'Body weight reduction ≥5%', 'timeFrame': 'At end of study (week 32)', 'description': 'Participants (yes/no).'}, {'measure': 'HbA1c reduction ≥1%-point and BW reduction ≥5%', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Participants (yes/no).'}, {'measure': 'HbA1c reduction ≥1%-point and BW reduction ≥3%', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Participants (yes/no).'}, {'measure': 'Change in waist circumference', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in centimeter (cm).'}, {'measure': 'Change in blood pressure (BP) (systolic and diastolic)', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in millimeter of mercury (mmHg).'}, {'measure': 'Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in mmol/L.'}, {'measure': 'Change in high sensitive C-reactive protein (hsCRP)', 'timeFrame': 'From Baseline to end of study (week 32)', 'description': 'Measured in milligram per liter (mg/l).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participant diagnosed with T2D and without any prior or current use of oral semaglutide.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n* 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.\n* Male or female, adults above or equal to 18 years of age at the time of signing informed consent.\n* Diagnosed with type 2 diabetes mellitus.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Previous participation in this study (defined as having given informed consent in this study earlier).\n* Treatment with any investigational drug within 30 days prior to enrolment into the study.\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n* Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the Treatment Initiation visit (V1).\n* Patients diagnosed with type 1 diabetes mellitus.\n* Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration."}, 'identificationModule': {'nctId': 'NCT06269120', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NN9924-7787'}, 'secondaryIdInfos': [{'id': 'U1111-1290-8109', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 2 diabetes', 'description': '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.', 'interventionNames': ['Drug: Oral Semaglutide']}], 'interventions': [{'name': 'Oral Semaglutide', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Patients with type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7801', 'city': 'Siklós', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Siklósi Kórház, Diabetológia', 'geoPoint': {'lat': 45.85499, 'lon': 18.29752}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}