Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-11 @ 6:10 PM
Study NCT ID:
NCT01751360
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SYR-472 Open-label Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595449', 'term': 'trelagliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose', 'timeFrame': '7 days', 'description': 'Blood Glucose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.\n\n2\\. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.\n\nExclusion Criteria:\n\n-1. The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease\n\n. 2. The participant is assessed to be ineligible for the study by the investigator or subinvestigator.'}, 'identificationModule': {'nctId': 'NCT01751360', 'briefTitle': 'SYR-472 Open-label Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'orgStudyIdInfo': {'id': 'SYR-472/OCT-002'}, 'secondaryIdInfos': [{'id': 'U1111-1137-2768', 'type': 'REGISTRY', 'domain': 'UTN (WHO)'}, {'id': 'JapicCTI-122024', 'type': 'REGISTRY', 'domain': 'JapicCTI (Japan)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SYR-472 100mg', 'description': 'SYR-472 100mg', 'interventionNames': ['Drug: SYR-472']}], 'interventions': [{'name': 'SYR-472', 'type': 'DRUG', 'armGroupLabels': ['SYR-472 100mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan'}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}