Viewing Study NCT00479466

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Ignite Creation Date: 2025-12-24 @ 4:43 PM
Ignite Modification Date: 2026-01-04 @ 4:50 PM
Study NCT ID: NCT00479466
Status: TERMINATED
Last Update Posted: 2015-09-09
First Post: 2007-05-25
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose-Range Finding Study for MK0893 (0893-008)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Colombia', 'Germany', 'Hong Kong', 'Hungary', 'India', 'Israel', 'Malaysia', 'Mexico', 'New Zealand', 'Norway', 'Peru', 'Philippines', 'United States']}, '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': 'C575263', 'term': 'N-((4-(1-(3-(3,5-dichlorophenyl)-5-(6-methoxynaphthalen-2-yl)-1H-pyrazol-1-yl)ethyl)phenyl)carbonyl)-beta-alanine'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy, thus the study was discontinued.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 57, 'otherNumAffected': 16, 'seriousNumAtRisk': 57, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'MK0893 20 mg', 'otherNumAtRisk': 57, 'otherNumAffected': 11, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK0893 40 mg', 'otherNumAtRisk': 57, 'otherNumAffected': 22, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'MK0893 60 mg', 'otherNumAtRisk': 58, 'otherNumAffected': 16, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MK0893 80 mg', 'otherNumAtRisk': 56, 'otherNumAffected': 12, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Metformin HCL', 'otherNumAtRisk': 57, 'otherNumAffected': 13, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'MK0893 20 mg'}, {'id': 'OG002', 'title': 'MK0893 40 mg'}, {'id': 'OG003', 'title': 'MK0893 60 mg'}, {'id': 'OG004', 'title': 'MK0893 80 mg'}, {'id': 'OG005', 'title': 'Metformin HCL'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-11.4', 'upperLimit': '7.8'}, {'value': '-32.4', 'groupId': 'OG001', 'lowerLimit': '-41.7', 'upperLimit': '-23.2'}, {'value': '-48.4', 'groupId': 'OG002', 'lowerLimit': '-57.4', 'upperLimit': '-39.5'}, {'value': '-53.0', 'groupId': 'OG003', 'lowerLimit': '-61.9', 'upperLimit': '-44.1'}, {'value': '-63.0', 'groupId': 'OG004', 'lowerLimit': '-72.4', 'upperLimit': '-53.7'}, {'value': '-37.3', 'groupId': 'OG005', 'lowerLimit': '-46.3', 'upperLimit': '-28.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.6', 'ciLowerLimit': '-44.0', 'ciUpperLimit': '-17.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.6', 'ciLowerLimit': '-59.7', 'ciUpperLimit': '-33.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.1', 'ciLowerLimit': '-64.3', 'ciUpperLimit': '-38.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.2', 'ciLowerLimit': '-74.6', 'ciUpperLimit': '-47.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.5', 'ciLowerLimit': '-48.6', 'ciUpperLimit': '-22.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'MK0893 20 mg'}, {'id': 'OG002', 'title': 'MK0893 40 mg'}, {'id': 'OG003', 'title': 'MK0893 60 mg'}, {'id': 'OG004', 'title': 'MK0893 80 mg'}, {'id': 'OG005', 'title': 'Metformin HCL'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.82'}, {'value': '-0.60', 'groupId': 'OG001', 'lowerLimit': '-0.87', 'upperLimit': '-0.33'}, {'value': '-0.99', 'groupId': 'OG002', 'lowerLimit': '-1.25', 'upperLimit': '-0.73'}, {'value': '-1.14', 'groupId': 'OG003', 'lowerLimit': '-1.40', 'upperLimit': '-0.89'}, {'value': '-1.52', 'groupId': 'OG004', 'lowerLimit': '-1.79', 'upperLimit': '-1.25'}, {'value': '-0.78', 'groupId': 'OG005', 'lowerLimit': '-1.04', 'upperLimit': '-0.52'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-0.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '-1.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.69', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '-1.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.06', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '-1.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.32', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-0.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'MK0893 20 mg'}, {'id': 'OG002', 'title': 'MK0893 40 mg'}, {'id': 'OG003', 'title': 'MK0893 60 mg'}, {'id': 'OG004', 'title': 'MK0893 80 mg'}, {'id': 'OG005', 'title': 'Metformin HCL'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.1', 'groupId': 'OG000', 'lowerLimit': '-24.6', 'upperLimit': '8.4'}, {'value': '-64.9', 'groupId': 'OG001', 'lowerLimit': '-80.3', 'upperLimit': '-49.5'}, {'value': '-78.1', 'groupId': 'OG002', 'lowerLimit': '-92.4', 'upperLimit': '-63.8'}, {'value': '-95.5', 'groupId': 'OG003', 'lowerLimit': '-110.0', 'upperLimit': '-80.9'}, {'value': '-109.7', 'groupId': 'OG004', 'lowerLimit': '-125.1', 'upperLimit': '-94.3'}, {'value': '-68.9', 'groupId': 'OG005', 'lowerLimit': '-83.4', 'upperLimit': '-54.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.8', 'ciLowerLimit': '-79.4', 'ciUpperLimit': '-34.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 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{'value': '25', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '174', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'whyStopped': 'Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-08', 'studyFirstSubmitDate': '2007-05-25', 'resultsFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2007-05-25', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-07', 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Week 12'}, {'measure': 'Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)', 'timeFrame': 'Week 12'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes 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Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': '0893-008'}, 'secondaryIdInfos': [{'id': '2007_526'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK0893 80 mg', 'description': 'MK0893 tablets totaling 80 mg once daily.', 'interventionNames': ['Drug: MK0893', 'Drug: Placebo to MK0893', 'Drug: Placebo to Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'MK0893 60 mg', 'description': 'MK0893 tablets totaling 60 mg once daily.', 'interventionNames': ['Drug: MK0893', 'Drug: Placebo to MK0893', 'Drug: Placebo to Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'MK0893 40 mg', 'description': 'MK0893 40 mg tablet once daily.', 'interventionNames': ['Drug: MK0893', 'Drug: Placebo to MK0893', 'Drug: Placebo to Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'MK0893 20 mg', 'description': 'MK0893 20 mg tablet once daily.', 'interventionNames': ['Drug: MK0893', 'Drug: Placebo to MK0893', 'Drug: Placebo to 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'armGroupLabels': ['MK0893 20 mg', 'MK0893 40 mg', 'MK0893 60 mg', 'MK0893 80 mg', 'Metformin', 'Placebo']}, {'name': 'Placebo to Metformin', 'type': 'DRUG', 'description': 'Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.', 'armGroupLabels': ['MK0893 20 mg', 'MK0893 40 mg', 'MK0893 60 mg', 'MK0893 80 mg', 'Placebo']}]}, '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'}}}}