Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-04-21 @ 12:05 PM
Study NCT ID:
NCT02284269
Status:
UNKNOWN
Last Update Posted:
2016-04-04
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular events', 'timeFrame': 'up to 3 years'}, {'measure': 'Incidence of cancer', 'timeFrame': 'up to 3 years'}, {'measure': 'The change from baseline in vital signs and laboratory data', 'timeFrame': 'Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration'}, {'measure': 'Incidence of other adverse events', 'timeFrame': 'up to 3 years'}, {'measure': 'Incidence of drug-related adverse events', 'timeFrame': 'up to 3 years'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': 'up to 3 years'}, {'measure': 'The change from baseline in HbA1c', 'timeFrame': 'Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration'}, {'measure': 'The change from baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.\n\nIn each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors'}, 'identificationModule': {'nctId': 'NCT02284269', 'briefTitle': 'Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pharmaceuticals and Medical Devices Agency, Japan'}, 'officialTitle': 'Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PMDA-A2602'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SGLT2 Inhibitors', 'type': 'DRUG', 'description': 'Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmaceuticals and Medical Devices Agency, Japan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}