Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-13 @ 10:54 PM
Study NCT ID:
NCT00543361
Status:
TERMINATED
Last Update Posted:
2015-06-12
First Post:
2007-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.', 'timeFrame': 'over the course of 52 weeks'}], 'secondaryOutcomes': [{'measure': 'MK0767 will be safe and well tolerated.', 'timeFrame': 'over the course of 52 weeks'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are men and non-pregnant women ages 21 to 78 years\n* Patients either not on antihyperglycemic medications (\\>8 weeks), or being treated with a single oral antihyperglycemic agent \\& willing to discontinue therapy for the duration of the study\n\nExclusion Criteria:\n\n* Patient has history of type 1 diabetes mellitus and or history of ketoacidosis\n* Patients undergoing surgery within 30 days of Visit 1\n* Patients taking Warfin or Warfin-like anticoagulants\n* Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9'}, 'identificationModule': {'nctId': 'NCT00543361', 'briefTitle': 'Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise', 'orgStudyIdInfo': {'id': '0767-020'}, 'secondaryIdInfos': [{'id': 'MK0767-020'}, {'id': '2007_627'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0767', 'type': 'DRUG', 'description': 'Duration of Treatment: 52 Weeks'}, {'name': 'Comparator: placebo (unspecified)', 'type': 'DRUG', 'description': 'Duration of Treatment: 52 Weeks'}, {'name': 'Comparator: metformin', 'type': 'DRUG', 'description': 'Duration of Treatment: 52 Weeks'}]}, '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'}}}}