Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT00875394
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
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'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}]}}, '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': 'A limited number of participants were recruited into this open-label study. This study was conducted at a single site.\n\nProtocol deviations may have occurred that resulted in quality issues associated with reporting of the data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin + Metformin', 'description': 'Patients administered sitagliptin and metformin', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metformin + Any Non-DPP-4i Oral Antidiabetic Drug', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".', 'otherNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Metformin Alone', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MEDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MEDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin + Metformin', 'description': 'Patients administered sitagliptin and metformin.'}, {'id': 'OG001', 'title': 'Metformin + Any Non-DPP-4i Oral Antidiabetic Drug', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}, {'id': 'OG002', 'title': 'Metformin Alone', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}], 'timeFrame': 'Baseline and 24 weeks', 'description': 'Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin + Metformin', 'description': 'Patients administered sitagliptin and metformin'}, {'id': 'FG001', 'title': 'Metformin + Any Non-DPP-4i Oral Antidiabetic Drug', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}, {'id': 'FG002', 'title': 'Metformin Alone', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients were recruited in Principal Investigator's private practice, in Mexico City.\n\nFirst Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008", 'preAssignmentDetails': 'Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or "standard care" added to ongoing metformin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin + Metformin', 'description': 'Patients administered sitagliptin and metformin'}, {'id': 'BG001', 'title': 'Metformin + Any Non-DPP-4i Oral Antidiabetic Drug', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}, {'id': 'BG002', 'title': 'Metformin Alone', 'description': 'Patients in the \'standard care\' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '54.69', 'spread': '9.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '28.84', 'spread': '4.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin A1C (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '8.47', 'spread': '1.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since diagnosis of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '10.9', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '8.43', 'spread': '7.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2009-04-01', 'resultsFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-04-02', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-03-22', 'studyFirstPostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'descriptionModule': {'briefSummary': 'After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient Has Type 2 Diabetes Mellitus\n* Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent\n* Patient Is Currently On Metformin Therapy (1500 Mg/Day)\n* Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \\>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication\n* Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent\n* Patient Has An A1c of 6.5 % - 11.0%\n\nExclusion Criteria:\n\n* Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis'}, 'identificationModule': {'nctId': 'NCT00875394', 'briefTitle': 'Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin', 'orgStudyIdInfo': {'id': '0431-189'}, 'secondaryIdInfos': [{'id': '2009_571'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'sitagliptin + metformin', 'interventionNames': ['Drug: sitagliptin phosphate', 'Drug: Comparator: metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'metformin + any other oral antidiabetic drug', 'interventionNames': ['Drug: Comparator: metformin', 'Drug: Comparator: Antidiabetic Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'metformin', 'interventionNames': ['Drug: Comparator: metformin']}], 'interventions': [{'name': 'sitagliptin phosphate', 'type': 'DRUG', 'otherNames': ['sitagliptin'], 'description': 'sitagliptin 100 mg Once a day (QD) for 24 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: metformin', 'type': 'DRUG', 'otherNames': ['metformin'], 'description': 'metformin 850 mg Twice a day (BID) for 24 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: metformin', 'type': 'DRUG', 'otherNames': ['metformin'], 'description': 'metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks', 'armGroupLabels': ['3']}, {'name': 'Comparator: Antidiabetic Standard of Care', 'type': 'DRUG', 'description': 'Patient can take any oral antidiabetic drug (other than metformin)', 'armGroupLabels': ['2']}]}, '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'}}}}