Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT01890993
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 952}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (glycosylated haemoglobin)', 'timeFrame': 'Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)'}, {'measure': 'Change in systolic blood pressure', 'timeFrame': 'Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (+/-2) months of available data will be included in this study. Only data derived from patients receiving either therapy in accordance with license indications will be included and analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months\n\nExclusion Criteria:\n\n* Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country'}, 'identificationModule': {'nctId': 'NCT01890993', 'briefTitle': 'Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe', 'orgStudyIdInfo': {'id': 'NN2211-4077'}, 'secondaryIdInfos': [{'id': 'U1111-1142-2764', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'ENCEPP/SDPP/8135', 'type': 'OTHER', 'domain': 'EU PAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liraglutide', 'interventionNames': ['Drug: liraglutide']}, {'label': 'DPP-4', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': "Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.", 'armGroupLabels': ['DPP-4', 'Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92932', 'city': 'Paris La Défense Cedex', 'country': 'France'}, {'zip': '55127', 'city': 'Mainz', 'country': 'Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'RH11 9RT', 'city': 'Crawley', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}