Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 4:22 AM
Study NCT ID:
NCT05443334
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2022-06-29
Is 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 Spain, 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': 465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured in percentage (%)-points'}], 'secondaryOutcomes': [{'measure': 'Relative change in body weight', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured in percentage (%)'}, {'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 < 7%', 'timeFrame': 'End of Study visit (V3) (week 34- 44)', 'description': 'Measured as Yes or No'}, {'measure': 'HbA1c reduction >=1%-points and body weight reduction of >=5%', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured as Yes or No'}, {'measure': 'HbA1c reduction >=1%-points and body weight reduction of >=3%', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured as Yes or No'}, {'measure': 'DTSQc, relative treatment satisfaction', 'timeFrame': 'End of Study visit (V3) (week 34- 44)', 'description': 'Measured in Total score'}, {'measure': 'DTSQs, change in absolute treatment satisfaction', 'timeFrame': 'From baseline (week 0) to End of Study visit (V3) (week 34-44)', 'description': 'Measured in Total score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '40555703', 'type': 'DERIVED', 'citation': 'Delgado Alvarez E, Morales Portillo C, Abreu Padin C, Aliaga Verdugo A, Piera Carbonell A, Cadenas Gonzalez A, Amor Valero J, Gonzalez Lopez V, Rasmussen CL, Scheuer SH, Bellido Guerrero D. PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes. Diabetes Obes Metab. 2025 Sep;27(9):4812-4824. doi: 10.1111/dom.16523. Epub 2025 Jun 24.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by 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': 'Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.', '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* Diagnosed with type 2 diabetes mellitus\n* 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\n* Male or female, age above or equal to 18 years at the time of signing informed consent\n* Available HbA1c value less than 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\n* Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study\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"}, 'identificationModule': {'nctId': 'NCT05443334', 'acronym': 'PIONEER REAL', 'briefTitle': 'A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Spain, 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 Spain', 'orgStudyIdInfo': {'id': 'NN9924-4547'}, 'secondaryIdInfos': [{'id': 'U1111-1240-4149', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with type 2 diabetes', 'description': 'Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.', 'interventionNames': ['Drug: Semaglutide']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Participants 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 participant in this study.', 'armGroupLabels': ['Participants with type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Master Centre for Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Master Centre for Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], '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'}}}}