Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01223456
Status:
TERMINATED
Last Update Posted:
2013-10-08
First Post:
2010-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 542}}, 'statusModule': {'whyStopped': 'Inability to recruit adequate number of patients within the specified time period.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-07', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events observed during the treatment duration', 'timeFrame': 'Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up'}, {'measure': 'Clinical Response determined by cure rate', 'timeFrame': 'Up to three (3) months after initiation of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Saxagliptin', 'type 2 diabetes', 'clinical practice'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'several private and government hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Type 2 Diabetes Mellitus\n* Prescribed Saxagliptin by patient's attending physician\n\nExclusion Criteria:\n\n* Known allergic or serious adverse reaction to Saxagliptin\n* Pregnant or breastfeeding patients"}, 'identificationModule': {'nctId': 'NCT01223456', 'acronym': 'ONGLYZA PMS', 'briefTitle': 'Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines', 'orgStudyIdInfo': {'id': 'NIS-CPH-DUM-2010/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Batangas', 'state': 'Batangas', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 13.7567, 'lon': 121.0584}}, {'city': 'Cebu City', 'state': 'Cebu', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Davao City', 'state': 'Davao Region', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'city': 'Iloilo City', 'state': 'Iloilo', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 10.69694, 'lon': 122.56444}}, {'city': 'Las Piñas', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.45056, 'lon': 120.98278}}, {'city': 'Makati', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 16.412, 'lon': 121.1226}}, {'city': 'Manila', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Pasig', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'city': 'Quezon City', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Mabalacat', 'state': 'Pampanga', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 15.22303, 'lon': 120.57117}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Milagros Tan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Philippines'}, {'name': 'Emmanuel Arca, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca Philippines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}