Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT05443568
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Israel, as Part of Local Clinical Practice
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': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (Glycated haemoglobin)', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured as percent-points'}], 'secondaryOutcomes': [{'measure': 'Relative change in body weight', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured as Percent'}, {'measure': 'Absolute change in body weight', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured in Kilogram (Kg)'}, {'measure': 'HbA1c below 7%', 'timeFrame': 'End of Study visit (V3) (week 34-44)', 'description': 'Percentage of participants achieving or not achieving the target value'}, {'measure': 'HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5%', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Percentage of participants achieving or not achieving the reduction'}, {'measure': 'HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3%', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Percentage of patients achieving or not achieving the reduction'}, {'measure': 'DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction', 'timeFrame': 'End of Study visit (V3) (week 34-44)', 'description': 'The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a Total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc Total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.'}, {'measure': 'DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)\n2. Diagnosed with type 2 diabetes mellitus\n3. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the Specialist based on local label before and independently from the decision to include the patient in this study\n4. Male or female, age above or equal to 18 years at the time of signing informed consent\n5. Available HbA1c value below or equal to 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\n6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of below 14 days\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study\n2. Treatment with any investigational drug within 30 days prior to enrolment into the study\n3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation"}, 'identificationModule': {'nctId': 'NCT05443568', 'acronym': 'PIONEER REAL', 'briefTitle': 'A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Israel, as Part of Local Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Israel', 'orgStudyIdInfo': {'id': 'NN9924-4644'}, 'secondaryIdInfos': [{'id': 'U1111-1240-4321', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with type 2 diabetes', 'description': 'Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.', '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. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.', 'armGroupLabels': ['Patients with type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44425', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Master Centre for Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], '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'}}}}