Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-27 @ 3:30 AM
Study NCT ID:
NCT00543595
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2007-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585925', 'term': 'MK-0916'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-12', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '21272190', 'type': 'RESULT', 'citation': 'Feig PU, Shah S, Hermanowski-Vosatka A, Plotkin D, Springer MS, Donahue S, Thach C, Klein EJ, Lai E, Kaufman KD. Effects of an 11beta-hydroxysteroid dehydrogenase type 1 inhibitor, MK-0916, in patients with type 2 diabetes mellitus and metabolic syndrome. Diabetes Obes Metab. 2011 Jun;13(6):498-504. doi: 10.1111/j.1463-1326.2011.01375.x.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes Mellitus and Metabolic Syndrome.\n\nThis 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': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Type 2 Diabetes\n* 18 to 65 years of age\n\nExclusion Criteria:\n\n* History of Type 1 Diabetes Mellitus\n* Have been treated with insulin in the past 8 weeks\n* On a weight loss program and have ongoing weight loss\n* Taking weight loss medication\n* Have had surgery requiring general anesthesia in the past 30 days or have a planned surgery\n* Have taken another investigational drug in the last 8 weeks\n* Have active liver disease\n* Have a history of major surgery involving gastric or intestinal bypass'}, 'identificationModule': {'nctId': 'NCT00543595', 'briefTitle': 'MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'orgStudyIdInfo': {'id': '0916-005'}, 'secondaryIdInfos': [{'id': '2007_643'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0916', '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'}}}}