Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 11:41 PM
Study NCT ID:
NCT00758069
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2008-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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}, 'limitationsAndCaveats': {'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.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).', 'otherNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sitagliptin 50 mg BID', 'description': 'The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).', 'otherNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.', 'otherNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 24-hour Weighted Mean Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'OG001', 'title': 'Sitagliptin 50 mg BID', 'description': 'The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.9', 'groupId': 'OG000', 'lowerLimit': '-40.9', 'upperLimit': '28.9'}, {'value': '-28.6', 'groupId': 'OG001', 'lowerLimit': '-34.7', 'upperLimit': '22.4'}, {'value': '-9.0', 'groupId': 'OG002', 'lowerLimit': '-14.8', 'upperLimit': '-3.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-25.9', 'ciLowerLimit': '-34.2', 'ciUpperLimit': '-17.5', 'pValueComment': 'No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo', 'estimateComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-19.5', 'ciLowerLimit': '-28.0', 'ciUpperLimit': '-11.1', 'pValueComment': 'No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo', 'estimateComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'OG001', 'title': 'Sitagliptin 50 mg BID', 'description': 'The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.3', 'groupId': 'OG000', 'lowerLimit': '-27.7', 'upperLimit': '17.0'}, {'value': '-16.0', 'groupId': 'OG001', 'lowerLimit': '-21.4', 'upperLimit': '10.6'}, {'value': '-3.1', 'groupId': 'OG002', 'lowerLimit': '-8.2', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-19.3', 'ciLowerLimit': '-26.6', 'ciUpperLimit': '-11.9', 'pValueComment': 'No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo', 'estimateComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '-5.4', 'pValueComment': 'No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo', 'estimateComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'FG001', 'title': 'Sitagliptin 50 mg BID', 'description': 'The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Study enrolled slightly more than the target of N=20', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': 'Study enrolled slightly more than the target of N=20', 'groupId': 'FG001', 'numSubjects': '25'}, {'comment': 'Study enrolled slightly more than the target of N=20', 'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Incorrect Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Phase II.\n\nFirst patient in: 31 July 2005. Last patient, last visit: 13 February 2006.\n\nThe study was conducted at 8 centers in Japan.', 'preAssignmentDetails': 'Patients 20-69 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': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 100 mg QD', 'description': 'The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).'}, {'id': 'BG001', 'title': 'Sitagliptin 50 mg BID', 'description': 'The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '53.6', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '54.6', 'spread': '9.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '24-hour weighted mean plasma glucose (24hr-WMG)', 'classes': [{'categories': [{'measurements': [{'value': '195.0', 'spread': '55.6', 'groupId': 'BG000'}, {'value': '188.9', 'spread': '46.6', 'groupId': 'BG001'}, {'value': '195.4', 'spread': '46.2', 'groupId': 'BG002'}, {'value': '193.2', 'spread': '49.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The 24hr-WMG is the weighted mean of the blood glucose weighted by the intervals between time points for a day \\[i.e. the area under curve in glucose-time profile through 24-hours (AUC0-24 hr) divided by 24\\].', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '158.6', 'spread': '41.0', 'groupId': 'BG000'}, {'value': '156.4', 'spread': '41.3', 'groupId': 'BG001'}, {'value': '164.1', 'spread': '36.9', 'groupId': 'BG002'}, {'value': '159.9', 'spread': '39.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', '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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2006-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2008-09-22', 'resultsFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-09-24', 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 24-hour Weighted Mean Plasma Glucose', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Plasma Glucose', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '19253204', 'type': 'BACKGROUND', 'citation': 'Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy\n\nExclusion Criteria:\n\n* Patients Have Type 1 Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT00758069', 'briefTitle': 'Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects', 'orgStudyIdInfo': {'id': '0431-045'}, 'secondaryIdInfos': [{'id': 'MK0431-045'}, {'id': '2008_026'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Sitagliptin 100 mg', 'interventionNames': ['Drug: sitagliptin phosphate']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Sitagliptin 50 mg', 'interventionNames': ['Drug: Comparator: Sitagliptin']}], 'interventions': [{'name': 'sitagliptin phosphate', 'type': 'DRUG', 'otherNames': ['MK0431'], 'description': '100 mg once daily (QD), taken orally for 4 weeks', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo tablet, QD, taken orally for 4 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: Sitagliptin', 'type': 'DRUG', 'otherNames': ['MK0431'], 'description': '50 mg twice daily (BID), taken orally for 4 weeks', 'armGroupLabels': ['3']}]}, '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'}}}}