Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT00127192
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2005-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, '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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).', 'otherNumAffected': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).', 'otherNumAffected': 25, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).', 'otherNumAffected': 32, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).', 'otherNumAffected': 20, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.', 'otherNumAffected': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Albumin at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).'}, {'id': 'OG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).'}, {'id': 'OG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'OG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '1.5'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '2.2'}, {'value': '-2.6', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '2.1'}, {'value': '-2.9', 'groupId': 'OG003', 'lowerLimit': '-3.4', 'upperLimit': '2.5'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '-3.0', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '-2.6', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '-2.7', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-2.0', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline at Week 12 is defined as Week 12 minus Week 0.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).'}, {'id': 'OG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).'}, {'id': 'OG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'OG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '0.29'}, {'value': '-0.71', 'groupId': 'OG001', 'lowerLimit': '-0.83', 'upperLimit': '0.59'}, {'value': '-0.69', 'groupId': 'OG002', 'lowerLimit': '-0.81', 'upperLimit': '0.56'}, {'value': '-0.76', 'groupId': 'OG003', 'lowerLimit': '-0.89', 'upperLimit': '0.64'}, {'value': '0.28', 'groupId': 'OG004', 'lowerLimit': '0.16', 'upperLimit': '0.40'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Tukeys linear trend test based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.86', 'pValueComment': 'No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '-0.79', 'pValueComment': 'No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.82', 'pValueComment': 'No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.52', 'pValueComment': 'No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).'}, {'id': 'OG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).'}, {'id': 'OG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'OG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '5.3'}, {'value': '-11.4', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '6.8'}, {'value': '-14.6', 'groupId': 'OG002', 'lowerLimit': '-19.2', 'upperLimit': '9.9'}, {'value': '-16.9', 'groupId': 'OG003', 'lowerLimit': '-21.6', 'upperLimit': '12.1'}, {'value': '6.3', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '10.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-23.2', 'ciLowerLimit': '-29.8', 'ciUpperLimit': '-16.6', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-20.8', 'ciLowerLimit': '-27.4', 'ciUpperLimit': '-14.3', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-17.7', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '-11.2', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-15.9', 'ciLowerLimit': '-22.3', 'ciUpperLimit': '-9.6', 'pValueComment': 'Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.', 'estimateComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'Pairwise comparison based on ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline at Week 12 is defined as Week 12 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).'}, {'id': 'FG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).'}, {'id': 'FG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'FG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Study enrolled slightly more than the target of N=70', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'Study enrolled slightly more than the target of N=70', 'groupId': 'FG001', 'numSubjects': '72'}, {'comment': 'Study enrolled as per the target of N=70', 'groupId': 'FG002', 'numSubjects': '70'}, {'comment': 'Study enrolled slightly less than the target of N=70', 'groupId': 'FG003', 'numSubjects': '68'}, {'comment': 'Study enrolled slightly more than the target of N=70', 'groupId': 'FG004', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Adverse event in pre-treatment period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Phase II.\n\nFirst patient in: 11 July 2005. Last patient, last visit: 8 March 2006.\n\nThe study was conducted at 97 centers in Japan.', 'preAssignmentDetails': 'Patients 20-75 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and \\<10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '363', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 25 mg QD', 'description': 'The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).'}, {'id': 'BG001', 'title': 'Sitagliptin 50 mg QD', 'description': 'The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).'}, {'id': 'BG002', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'BG003', 'title': 'Sitagliptin 200 mg QD', 'description': 'The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '60.6', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '60.2', 'spread': '8.0', 'groupId': 'BG004'}, {'value': '59.8', 'spread': '8.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '139', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '224', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '145.7', 'spread': '37.6', 'groupId': 'BG000'}, {'value': '144.3', 'spread': '29.0', 'groupId': 'BG001'}, {'value': '142.6', 'spread': '31.8', 'groupId': 'BG002'}, {'value': '148.4', 'spread': '33.3', 'groupId': 'BG003'}, {'value': '156.5', 'spread': '35.1', 'groupId': 'BG004'}, {'value': '147.5', 'spread': '33.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated albumin', 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '22.0', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '21.9', 'spread': '4.5', 'groupId': 'BG002'}, {'value': '21.9', 'spread': '3.9', 'groupId': 'BG003'}, {'value': '23.7', 'spread': '4.5', 'groupId': 'BG004'}, {'value': '22.2', 'spread': '4.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '0.8', 'groupId': 'BG003'}, {'value': '7.7', 'spread': '0.9', 'groupId': 'BG004'}, {'value': '7.6', 'spread': '0.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2005-08-03', 'resultsFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-24', 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Albumin at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline at Week 12 is defined as Week 12 minus Week 0.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Change from baseline at Week 12 is defined as Week 12 minus Week 0.'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20332588', 'type': 'RESULT', 'citation': 'Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00127192', 'briefTitle': 'A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0431-044'}, 'secondaryIdInfos': [{'id': 'MK0431-044'}, {'id': '2005_037'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo QD 12-week', 'interventionNames': ['Drug: Comparator: placebo (unspecified)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '25 mg QD 12-week', 'interventionNames': ['Drug: sitagliptin phosphate']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '50 mg QD 12-week', 'interventionNames': ['Drug: sitagliptin phosphate']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '100 mg QD 12-week', 'interventionNames': ['Drug: sitagliptin phosphate']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': '200 mg QD 12-week', 'interventionNames': ['Drug: sitagliptin phosphate']}], 'interventions': [{'name': 'sitagliptin phosphate', 'type': 'DRUG', 'otherNames': ['MK0431'], 'description': 'sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.', 'armGroupLabels': ['2', '3', '4', '5']}, {'name': 'Comparator: placebo (unspecified)', 'type': 'DRUG', 'description': 'placebo QD 12-weeks', 'armGroupLabels': ['1']}]}, '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'}}}}