Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 6:03 AM
Study NCT ID:
NCT00854035
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2009-02-27', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '16 weeks'}, {'measure': 'Safety and Tolerability', 'timeFrame': '16 weeks and 52 weeks'}], 'secondaryOutcomes': [{'measure': '2 hour post-meal glucose', 'timeFrame': '16 weeks'}, {'measure': 'Fasting plasma glucose', 'timeFrame': '16 weeks'}]}, 'conditionsModule': {'keywords': ['MK-0431/ONO-5435', 'Type 2 diabetes mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy\n\nExclusion Criteria:\n\n* Patients with Type 1 Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT00854035', 'briefTitle': 'MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy', 'orgStudyIdInfo': {'id': 'ONO-5435-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E', 'interventionNames': ['Drug: MK-0431/ONO-5435']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'interventionNames': ['Drug: MK-0431/ONO-5435']}], 'interventions': [{'name': 'MK-0431/ONO-5435', 'type': 'DRUG', 'description': 'Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD', 'armGroupLabels': ['E']}, {'name': 'MK-0431/ONO-5435', 'type': 'DRUG', 'description': 'Double-blind period (16 wk); placebo QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD', 'armGroupLabels': ['P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Chugoku Region'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu Region', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokuriku', 'country': 'Japan', 'facility': 'Hokuriku Region'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Kyushu Region'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku Region', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Seki Akiteru', 'role': 'STUDY_CHAIR', 'affiliation': 'First Division Clinical Development Planning I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}