Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 5:26 AM
Study NCT ID:
NCT00813995
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2008-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, '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': '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': {'otherDetails': 'Following the multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'otherNumAtRisk': 197, 'otherNumAffected': 10, 'seriousNumAtRisk': 197, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 198, 'otherNumAffected': 13, 'seriousNumAtRisk': 198, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'POST PROCEDURAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SPINAL CORD INJURY CERVICAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'TENOSYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LIP AND/OR ORAL CAVITY CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'IIIrd NERVE PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'EPIGLOTTIC CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '-1.16', 'upperLimit': '-0.87'}, {'value': '-0.14', 'spread': '1.22', 'groupId': 'OG001', 'lowerLimit': '-0.28', 'upperLimit': '0.01'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Pairwise comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \\[randomization\\] measurement and a post-randomization measurement) using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.84', 'spread': '1.09', 'groupId': 'OG000', 'lowerLimit': '-1.07', 'upperLimit': '-0.62'}, {'value': '-0.01', 'spread': '1.31', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '0.20'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \\[randomization\\] measurement and a post-randomization measurement) using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.14', 'spread': '0.88', 'groupId': 'OG000', 'lowerLimit': '-1.35', 'upperLimit': '-0.93'}, {'value': '-0.21', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '0.02'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \\[randomization\\] measurement and a post-randomization measurement) using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.4', 'spread': '57.3', 'groupId': 'OG000', 'lowerLimit': '-51.5', 'upperLimit': '-35.3'}, {'value': '-10.0', 'spread': '60.0', 'groupId': 'OG001', 'lowerLimit': '-18.4', 'upperLimit': '-1.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \\[randomization\\] measurement and a post-randomization measurement) using last observation carried forward for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.3', 'spread': '39.1', 'groupId': 'OG000', 'lowerLimit': '-26.2', 'upperLimit': '-14.5'}, {'value': '0.5', 'spread': '40.1', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '6.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \\[randomization\\] measurement and a post-randomization measurement) using last observation carried forward for missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Clinical adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Laboratory adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour Post-meal Glucose', 'classes': [{'categories': [{'measurements': [{'value': '258.0', 'spread': '58.0', 'groupId': 'BG000'}, {'value': '258.7', 'spread': '63.2', 'groupId': 'BG001'}, {'value': '258.3', 'spread': '60.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '392 participants with available data: sitagliptin, n=192; placebo, n=196', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '173.4', 'spread': '39.3', 'groupId': 'BG000'}, {'value': '173.9', 'spread': '40.0', 'groupId': 'BG001'}, {'value': '173.7', 'spread': '39.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2008-12-19', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-09', 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.'}, {'measure': 'Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22672586', 'type': 'DERIVED', 'citation': 'Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 78 years of age\n* Currently on metformin monotherapy\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus or ketoacidosis\n* Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks\n* Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery\n* Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks\n* History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease\n* HIV positive\n* Pregnant, breast-feeding or planning to become pregnant during the study\n* User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence'}, 'identificationModule': {'nctId': 'NCT00813995', 'briefTitle': 'A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy', 'orgStudyIdInfo': {'id': '0431-074'}, 'secondaryIdInfos': [{'id': '2008_601'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'interventionNames': ['Drug: Comparator: Sitagliptin phosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'Comparator: Sitagliptin phosphate', 'type': 'DRUG', 'otherNames': ['GLUCOPHAGE®'], 'description': 'All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'otherNames': ['GLUCOPHAGE®'], 'description': 'All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.', 'armGroupLabels': ['Placebo']}]}, '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'}}}}