Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-28 @ 11:34 AM
Study NCT ID:
NCT01585792
Status:
COMPLETED
Last Update Posted:
2013-04-16
First Post:
2012-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind Comparative Study of TAK-875
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C557331', 'term': 'TAK-875'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-15', 'studyFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2012-04-25', 'lastUpdatePostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '4 weeks', 'description': 'Blood glucose'}]}, 'conditionsModule': {'conditions': ['Diabetic Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant is an outpatient.\n* The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n\nExclusion Criteria:\n\n* The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.\n* The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.'}, 'identificationModule': {'nctId': 'NCT01585792', 'briefTitle': 'Double Blind Comparative Study of TAK-875', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'orgStudyIdInfo': {'id': 'TAK-875/CPH-030'}, 'secondaryIdInfos': [{'id': 'U1111-1129-7907', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-121816', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-875 25 mg', 'interventionNames': ['Drug: TAK-875']}, {'type': 'EXPERIMENTAL', 'label': 'TAK-875 50 mg', 'interventionNames': ['Drug: TAK-875']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'interventionNames': ['Drug: Glimepiride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TAK-875', 'type': 'DRUG', 'armGroupLabels': ['TAK-875 25 mg']}, {'name': 'TAK-875', 'type': 'DRUG', 'armGroupLabels': ['TAK-875 50 mg']}, {'name': 'Glimepiride', 'type': 'DRUG', 'armGroupLabels': ['Glimepiride']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}