Viewing Study NCT00541450

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Ignite Creation Date: 2025-12-24 @ 4:54 PM
Ignite Modification Date: 2026-01-07 @ 12:10 AM
Study NCT ID: NCT00541450
Status: COMPLETED
Last Update Posted: 2017-05-12
First Post: 2007-10-05
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Croatia', 'Germany', 'Greece', 'Guatemala', 'Iceland', 'Italy', 'Peru', 'Poland', 'Saudi Arabia', 'Serbia', 'Slovenia', 'Turkey (Türkiye)', 'United Arab Emirates', 'United States', 'Venezuela']}, '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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000068899', 'term': 'Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialsdisclosure@spcorp.com', 'title': 'Vice President of Late Stage Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on the PI is that an investigator and/or his/her colleagues may publish the results for their study site independently subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Participants that received at least one dose of study medication, which was sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12 and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 were analyzed. The analyses for Week 0-40 did not include participants who discontinued from the study during Weeks 0-12.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin (Weeks 0-12)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.', 'otherNumAtRisk': 244, 'otherNumAffected': 7, 'seriousNumAtRisk': 244, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Pioglitazone (Weeks 0-12)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.', 'otherNumAtRisk': 248, 'otherNumAffected': 15, 'seriousNumAtRisk': 248, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Sita/Met FDC (Weeks 0-40)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.', 'otherNumAtRisk': 222, 'otherNumAffected': 20, 'seriousNumAtRisk': 222, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Pioglitazone (Weeks 0-40)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.\n\nIn Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d.', 'otherNumAtRisk': 230, 'otherNumAffected': 33, 'seriousNumAtRisk': 230, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infection parasitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.75', 'groupId': 'OG000', 'lowerLimit': '-1.92', 'upperLimit': '-1.59'}, {'value': '-1.38', 'groupId': 'OG001', 'lowerLimit': '-1.55', 'upperLimit': '-1.21'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 40 weeks', 'description': 'The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and\n\n(2) had a baseline measurement and at least one on-treatment measurement for A1C.'}, {'type': 'SECONDARY', 'title': 'Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.).'}], 'classes': [{'categories': [{'measurements': [{'value': '-90.3', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '-81.0'}, {'value': '-69.1', 'groupId': 'OG001', 'lowerLimit': '-78.2', 'upperLimit': '-60.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 40 weeks', 'description': 'The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and\n\n(2) had a baseline measurement and at least one on-treatment measurement for PMG.'}, {'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.'}, {'id': 'OG001', 'title': 'Pioglitazone (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'groupId': 'OG000', 'lowerLimit': '-1.18', 'upperLimit': '-0.88'}, {'value': '-0.87', 'groupId': 'OG001', 'lowerLimit': '-1.02', 'upperLimit': '-0.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.'}, {'type': 'SECONDARY', 'title': 'Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.'}, {'id': 'OG001', 'title': 'Pioglitazone (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.8', 'groupId': 'OG000', 'lowerLimit': '-62.4', 'upperLimit': '-43.3'}, {'value': '-50.1', 'groupId': 'OG001', 'lowerLimit': '-59.4', 'upperLimit': '-40.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for PMG.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.).'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.8', 'groupId': 'OG000', 'lowerLimit': '-51.1', 'upperLimit': '-40.5'}, {'value': '-37.6', 'groupId': 'OG001', 'lowerLimit': '-42.8', 'upperLimit': '-32.4'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 40 weeks', 'description': 'The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for FPG.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.'}, {'id': 'OG001', 'title': 'Pioglitazone (Phase A)', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.6', 'groupId': 'OG000', 'lowerLimit': '-31.7', 'upperLimit': '-21.5'}, {'value': '-28.0', 'groupId': 'OG001', 'lowerLimit': '-33.0', 'upperLimit': '-23.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for FPG.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.'}, {'id': 'FG001', 'title': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.).'}], 'periods': [{'title': 'Phase A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '231'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Creatinine/CrCl -Increase in creatinine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Hyperglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}, {'title': 'Phase B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Hyperglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks.'}, {'id': 'BG001', 'title': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.\n\nIn Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 492}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2007-10-05', 'resultsFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2007-10-05', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-11', 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks', 'timeFrame': 'Baseline to 40 weeks', 'description': 'The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.'}, {'measure': 'Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.'}], 'secondaryOutcomes': [{'measure': 'Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks', 'timeFrame': 'Baseline and 40 weeks', 'description': 'The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.'}, {'measure': 'Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks', 'timeFrame': 'Baseline and 40 weeks', 'description': 'The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21849007', 'type': 'RESULT', 'citation': 'Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 and 78 with type 2 diabetes mellitus\n* Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months\n\nExclusion Criteria:\n\n* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis\n* Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor'}, 'identificationModule': {'nctId': 'NCT00541450', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0431-068'}, 'secondaryIdInfos': [{'id': '2007_501'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sita/Met FDC', 'description': 'In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks.\n\nIn Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone.', 'interventionNames': ['Drug: Comparator: sitagliptin phosphate (sitagliptin)', 'Drug: sitagliptin phosphate (+) metformin hydrochloride', 'Drug: Matching placebo to pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d.\n\nIn Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks).', 'interventionNames': ['Drug: Comparator: pioglitazone', 'Drug: Matching placebo to sitagliptin', 'Drug: Matching Placebo to Sita/Met FDC']}], 'interventions': [{'name': 'Comparator: sitagliptin phosphate (sitagliptin)', 'type': 'DRUG', 'otherNames': ['MK0431, Januvia™'], 'description': 'sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period', 'armGroupLabels': ['Sita/Met FDC']}, {'name': 'sitagliptin phosphate (+) metformin hydrochloride', 'type': 'DRUG', 'otherNames': ['MK-0431A, Janumet™'], 'description': 'sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period', 'armGroupLabels': ['Sita/Met FDC']}, {'name': 'Comparator: pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos®'], 'description': 'pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Matching placebo to pioglitazone', 'type': 'DRUG', 'description': 'matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.\n\nParticipants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.', 'armGroupLabels': ['Sita/Met FDC']}, {'name': 'Matching placebo to sitagliptin', 'type': 'DRUG', 'description': 'matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Matching Placebo to Sita/Met FDC', 'type': 'DRUG', 'description': 'matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}