Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 2:30 PM
Study NCT ID:
NCT01345734
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2011-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Interventional Study on 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': 1056}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2011-04-29', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of serious adverse drug reactions (SADRs)', 'timeFrame': 'Week 0, week 26'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse drug reactions (ADRs)', 'timeFrame': 'Week 0, week 26'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'Week 0, week 26'}, {'measure': 'Frequency of hypoglycaemic episodes', 'timeFrame': 'Week 0, week 26'}, {'measure': 'Change in HbA1c (glycosylated haemoglobin)"', 'timeFrame': 'Week 0, week 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '33442116', 'type': 'RESULT', 'citation': 'Jimeno C, Kho S, de Los Santos GK, Buena-Bobis N, Villa M. The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes. J ASEAN Fed Endocr Soc. 2018;33(2):114-123. doi: 10.15605/jafes.033.02.02. Epub 2018 Oct 9.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects with type 2 diabetes, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than liraglutide.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician\n* Subjects who are capable of giving study-specific signed informed consent before any collection of information\n\nExclusion Criteria:\n\n* Subjects with type 1 diabetes\n* Subjects who are or have previously been on liraglutide\n* Subjects who are participating in another clinical trial\n* Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)\n* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months'}, 'identificationModule': {'nctId': 'NCT01345734', 'acronym': 'Lead-Ph', 'briefTitle': 'Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in Philippines', 'orgStudyIdInfo': {'id': 'NN2211-3932'}, 'secondaryIdInfos': [{'id': 'U1111-1119-8803', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liraglutide', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.', 'armGroupLabels': ['Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1605', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], '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'}}}}