Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT02255266
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2014-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice
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': 1788}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of patients achieving HbA1c reduction of at least 1%-point', 'timeFrame': 'Week 0, week 52'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c (Glycosylated haemoglobin))', 'timeFrame': 'Week 0, week 104'}, {'measure': 'Change in body weight', 'timeFrame': 'Week 0, week 104'}, {'measure': 'Frequency of patients achieving HbA1c reduction of at least 1%-point', 'timeFrame': 'After 4 and 24 months of treatment'}, {'measure': 'Frequency of patients achieving HbA1c target (<=7%)', 'timeFrame': 'After 4, 12 and 24 months'}, {'measure': 'Frequency of patients achieving a body weight reduction of at least 3%', 'timeFrame': 'After 4, 12 and 24 months'}, {'measure': 'Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3%', 'timeFrame': 'After 4, 12 and 24 months'}, {'measure': 'Percentage of treatment discontinuation for any reason', 'timeFrame': 'At 4, 12 and 24 months'}, {'measure': 'Changes in blood pressure and lipid profile', 'timeFrame': 'Week 0, week 104'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29270781', 'type': 'RESULT', 'citation': 'Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, Nicolucci A; NN2211-4118 Study Group. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study. Adv Ther. 2018 Feb;35(2):243-253. doi: 10.1007/s12325-017-0652-2. Epub 2017 Dec 21.'}], '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 investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting the inclusion criteria will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011\n\nExclusion Criteria:\n\n* None. Available data from all eligible patients for each center, will be included'}, 'identificationModule': {'nctId': 'NCT02255266', 'briefTitle': 'Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice', 'orgStudyIdInfo': {'id': 'NN2211-4118'}, 'secondaryIdInfos': [{'id': 'U1111-1143-9842', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'No treatment given.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], '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'}}}}