Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT01433393
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2011-09-12
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'}, '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': 'C557331', 'term': 'TAK-875'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-07', 'studyFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2011-09-12', 'lastUpdatePostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c'}]}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, '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\n1. The participant is an outpatient.\n2. 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\n1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.\n2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.'}, 'identificationModule': {'nctId': 'NCT01433393', 'briefTitle': 'Double-blind Comparative Study of TAK-875', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'orgStudyIdInfo': {'id': 'TAK-875/CCT-003'}, 'secondaryIdInfos': [{'id': 'U1111-1124-1518', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-111604', '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': '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': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisarazu-shi', 'state': 'Chiba', 'country': 'Japan'}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka-shi Nishi-ku', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Kasuga-shi', 'state': 'Fukuoka', 'country': 'Japan'}, {'city': 'Naka', 'state': 'Ibaragi', 'country': 'Japan', 'geoPoint': {'lat': 36.05, 'lon': 140.16667}}, {'city': 'Tsuchiura-shi', 'state': 'Ibaragi', 'country': 'Japan'}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Kyoto-shi Fushimi-ku', 'state': 'Kyoto', 'country': 'Japan'}, {'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Kashihara-shi', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.50896, 'lon': 135.7929}}, {'city': 'Kashiwara-shi', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Osaka-shi Tsurumi-ku', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Sakai-shi Nishi-ku', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Shimotsuke-shi', 'state': 'Tochigi', 'country': 'Japan'}, {'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}