Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-03 @ 4:28 AM
Study NCT ID:
NCT00686634
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sitagliptin in Combination With Metformin and Sulfonylurea
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': {'email': 'stanleyhsia@cdrewu.edu', 'phone': '323-357-3633', 'title': 'Stanley H. Hsia, MD', 'organization': 'Charles R. Drew University of Medicine and Science'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin Treatment', 'description': 'Sitagliptin 100 mg once daily', 'otherNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1c (HbA1c) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 months', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Any adverse events while receiving sitagliptin'}], 'classes': [{'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'Adverse event', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin Treatment', 'description': 'Sitagliptin 100 mg orally once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin Treatment', 'description': 'Sitagliptin 100 mg once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2008-05-27', 'resultsFirstSubmitDate': '2012-02-24', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-25', 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) Change From Baseline', 'timeFrame': 'Baseline, 4 months'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months', 'timeFrame': '4 months'}, {'measure': 'Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year', 'timeFrame': '1 year'}, {'measure': 'Number of Adverse Events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sitagliptin', 'type 2 diabetes', 'combination therapy'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21550951', 'type': 'DERIVED', 'citation': 'Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.', 'detailedDescription': 'The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18-75\n* Type 2 diabetes\n* At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) \\>7.0%)\n* Able to comply with all scheduled visits and requirements of the protocol\n\nExclusion Criteria:\n\n* Any contraindications to the use of metformin or a sulfonylurea agent\n* Extreme hyperglycemia or symptoms of polyuria or polydipsia\n* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)\n* History of confirmed (or clinical suspicion of) type 1 diabetes mellitus\n* Episodes of symptomatic hypoglycemia averaging greater than once per day\n* Estimated glomerular filtration rate (eGFR) \\< 60 mL/min\n* Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable\n* History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.\n* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception\n* Current pregnancy or lactation.\n* Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.\n* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry\n* Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.'}, 'identificationModule': {'nctId': 'NCT00686634', 'briefTitle': 'Sitagliptin in Combination With Metformin and Sulfonylurea', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes', 'orgStudyIdInfo': {'id': '07-06-002'}, 'secondaryIdInfos': [{'id': 'U54RR014616', 'link': 'https://reporter.nih.gov/quickSearch/U54RR014616', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Sitagliptin 100 mg once daily', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Trade name: Januvia'], 'description': 'Sitagliptin 100 mg by mouth once daily', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles Drew University of Medicine and Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Stanley Hsia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles Drew University of Medicine and Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}