Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-25 @ 3:36 AM
Study NCT ID:
NCT00543751
Status:
TERMINATED
Last Update Posted:
2015-06-17
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-16', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-12', 'lastUpdatePostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy\n* Non-pregnant females\n\nExclusion Criteria:\n\n* Patients with Type 1 Diabetes or history of ketoacidosis\n* Patients who have been treated with insulin or other antihyperglycemic agents\n* Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease'}, 'identificationModule': {'nctId': 'NCT00543751', 'briefTitle': 'Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'orgStudyIdInfo': {'id': '0767-025'}, 'secondaryIdInfos': [{'id': '2007_634'}, {'id': 'MK-0767-025'}]}, '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'}}}}