Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-13 @ 11:21 AM
Study NCT ID:
NCT01817569
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2948}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event incidence.', 'timeFrame': '3 years', 'description': 'Number of Adverse Drug Reactions'}], 'secondaryOutcomes': [{'measure': 'Mean change of HbA1c.', 'timeFrame': '3 years', 'description': 'Change value of HbA1c from baseline as mean / median / minimum / max.'}, {'measure': 'Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).', 'timeFrame': '3 years', 'description': 'The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment.'}, {'measure': 'Mean change in weight.', 'timeFrame': '3 years'}, {'measure': 'Mean change in blood pressure.', 'timeFrame': '3 years.'}, {'measure': 'Mean change in lipid metabolism.', 'timeFrame': '3 years', 'description': 'Change value of lipid metabolism from baseline as mean / median / minimum / max.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus (DM)', 'Byetta', 'Exenatide'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5550C00001&attachmentIdentifier=846e4155-9a58-400f-86e0-771d7a6d697a&fileName=D5550C00001_redacted_CSR_synopsis.PDF&versionIdentifier=', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices', 'detailedDescription': 'Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are eligible to be included in the study if they meet all of the following criteria:\n\nThe patient who is diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.\n\nThe patient follows the PI of Byetta.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.'}, 'identificationModule': {'nctId': 'NCT01817569', 'briefTitle': 'Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)', 'orgStudyIdInfo': {'id': 'D5550C00001'}, 'secondaryIdInfos': [{'id': 'EUPAS19606', 'type': 'REGISTRY', 'domain': 'ENCePP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Byetta'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D5550C00001', 'city': 'Aichi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': 'D5550C00001', 'city': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': 'D5550C00001', 'city': 'Aomori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'zip': 'D5550C00001', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': 'D5550C00001', 'city': 'Ehime', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': 'D5550C00001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': 'D5550C00001', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': 'D5550C00001', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': 'D5550C00001', 'city': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': 'D5550C00001', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': 'D5550C00001', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': 'D5550C00001', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': 'D5550C00001', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': 'D5550C00001', 'city': 'Ishikawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'zip': 'D5550C00001', 'city': 'Kagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'zip': 'D5550C00001', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': 'D5550C00001', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': 'D5550C00001', 'city': 'Kochi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': 'D5550C00001', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': 'D5550C00001', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': 'D5550C00001', 'city': 'Mie', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'zip': 'D5550C00001', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': 'D5550C00001', 'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': 'D5550C00001', 'city': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': 'D5550C00001', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': 'D5550C00001', 'city': 'Nara', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': 'D5550C00001', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': 'D5550C00001', 'city': 'Numakunai', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'zip': 'D5550C00001', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': 'D5550C00001', 'city': 'Okinawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'zip': 'D5550C00001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': 'D5550C00001', 'city': 'Ōita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': 'D5550C00001', 'city': 'Saga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': 'D5550C00001', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': 'D5550C00001', 'city': 'Shiga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'zip': 'D5550C00001', 'city': 'Shimane', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'zip': 'D5550C00001', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': 'D5550C00001', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': 'D5550C00001', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': 'D5550C00001', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'D5550C00001', 'city': 'Tottori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'zip': 'D5550C00001', 'city': 'Toyama', 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