Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 2:00 PM
Study NCT ID:
NCT01226966
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2010-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%', 'timeFrame': 'Month 24'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c at month 3', 'timeFrame': 'Month 0, Month 3'}, {'measure': 'Change in HbA1c at month 6', 'timeFrame': 'Month 0, Month 6'}, {'measure': 'Change in HbA1c at month 12', 'timeFrame': 'Month 0, Month 12'}, {'measure': 'Change in HbA1c at month 18', 'timeFrame': 'Month 0, Month 18'}, {'measure': 'Change in HbA1c at month 24', 'timeFrame': 'Month 0, Month 24'}, {'measure': 'Change in fasting plasma glucose (FPG) at month 3', 'timeFrame': 'Month 0, Month 3'}, {'measure': 'Change in fasting plasma glucose (FPG) at month 6', 'timeFrame': 'Month 0, Month 6'}, {'measure': 'Change in fasting plasma glucose (FPG) at month 12', 'timeFrame': 'Month 0, Month 12'}, {'measure': 'Change in fasting plasma glucose (FPG) at month 18', 'timeFrame': 'Month 0, Month 18'}, {'measure': 'Change in fasting plasma glucose (FPG) at month 24', 'timeFrame': 'Month 0, Month 24'}, {'measure': 'Change in Body Weight at Month 3', 'timeFrame': 'Month 0, Month 3'}, {'measure': 'Change in Body Weight at Month 6', 'timeFrame': 'Month 0, Month 6'}, {'measure': 'Change in Body Weight at Month 12', 'timeFrame': 'Month 0, Month 12'}, {'measure': 'Change in Body Weight at Month 18', 'timeFrame': 'Month 0, Month 18'}, {'measure': 'Change in Body Weight at Month 24', 'timeFrame': 'Month 0, Month 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '26424330', 'type': 'RESULT', 'citation': 'Gautier JF, Martinez L, Penfornis A, Eschwege E, Charpentier G, Huret B, Madani S, Gourdy P. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study. Adv Ther. 2015 Sep;32(9):838-53. doi: 10.1007/s12325-015-0245-x. Epub 2015 Sep 30.'}, {'pmid': '28138803', 'type': 'RESULT', 'citation': 'Martinez L, Penfornis A, Gautier JF, Eschwege E, Charpentier G, Bouzidi A, Gourdy P. Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study. Adv Ther. 2017 Mar;34(3):674-685. doi: 10.1007/s12325-017-0476-0. Epub 2017 Jan 30.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 2 diabetes\n* Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment\n\nExclusion Criteria:\n\n* Hypersensitivity (allergy) to liraglutide or to any of the excipients\n* Patient is participating in a clinical trial at the inclusion\n* Type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT01226966', 'acronym': 'EVIDENCE', 'briefTitle': 'Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN2211-3815'}, 'secondaryIdInfos': [{'id': 'U1111-1116-2722', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92932', 'city': 'Paris La Défense Cedex', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site'}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452), Medical Advisor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}