Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-04-10 @ 8:32 PM
Study NCT ID:
NCT00543556
Status:
TERMINATED
Last Update Posted:
2015-06-15
First Post:
2007-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MK0767 in Type 2 Diabetes (0767-012)
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': 'C487303', 'term': 'MK0767'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-12', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive\n* Patient is willing to discontinue current therapy for the duration of the study\n* Patient is not a heavy drinker\n\nExclusion Criteria:\n\n* Patient has a history of Type 1 diabetes and/or ketoacidosis\n* Patient has severe diabetic retinopathy, or nephropathy, or neuropath\n* Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1\n* Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments'}, 'identificationModule': {'nctId': 'NCT00543556', 'briefTitle': 'MK0767 in Type 2 Diabetes (0767-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'orgStudyIdInfo': {'id': '0767-012'}, 'secondaryIdInfos': [{'id': '2007_640'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0767', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}