Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-27 @ 1:17 PM
Study NCT ID:
NCT01859793
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2013-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'mwidlans@mcw.edu', 'phone': '414-955-6806', 'title': 'Michael E. Widlansky', 'organization': 'Medical College of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No limitations noted.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Matching Placebo', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally', 'otherNumAtRisk': 36, 'otherNumAffected': 1, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sitagliptin', 'description': '100mg pill, PO administered once daily.\n\nsitagliptin: 100 mg pill, administered once/day orally', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'notes': '1 subject developed a minor rash along the subjects belt line during the study and was withdrawn from the study. The subject was on placebo at the time as discovered following unblinding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brachial Artery Flow Mediated Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': '100mg pill, PO administered once daily.\n\nsitagliptin: 100 mg pill, administered once/day orally'}], 'classes': [{'title': 'Prior To Intervention', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': '2 hours post acute dose', 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Following 8 weeks of therapy', 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change before and after a single dose (2 hours post) and 8 weeks after daily dosing', 'description': 'A measurement of endothelial function in humans', 'unitOfMeasure': '%FMD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 30 subjects who completed both arms of the cross-over study'}, {'type': 'SECONDARY', 'title': 'Circulating Inflammatory Marker ICAM-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': '100mg pill, PO administered once daily.\n\nsitagliptin: 100 mg pill, administered once/day orally'}], 'classes': [{'title': 'Pre-Intervention', 'categories': [{'measurements': [{'value': '226', 'spread': '72', 'groupId': 'OG000'}, {'value': '223', 'spread': '73', 'groupId': 'OG001'}]}]}, {'title': '2 hours post acute dose', 'categories': [{'measurements': [{'value': '216', 'spread': '73', 'groupId': 'OG000'}, {'value': '211', 'spread': '68', 'groupId': 'OG001'}]}]}, {'title': 'post 8 weeks of therapy', 'categories': [{'measurements': [{'value': '228', 'spread': '73', 'groupId': 'OG000'}, {'value': '232', 'spread': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded'}, {'type': 'SECONDARY', 'title': 'Circulating Inflammatory Markers VCAM-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': '100mg pill, PO administered once daily.\n\nsitagliptin: 100 mg pill, administered once/day orally'}], 'classes': [{'title': 'Pre-Intervention', 'categories': [{'measurements': [{'value': '584', 'spread': '187', 'groupId': 'OG000'}, {'value': '608', 'spread': '164', 'groupId': 'OG001'}]}]}, {'title': '2 hours post acute dose', 'categories': [{'measurements': [{'value': '575', 'spread': '141', 'groupId': 'OG000'}, {'value': '574', 'spread': '157', 'groupId': 'OG001'}]}]}, {'title': 'post 8 weeks of therapy', 'categories': [{'measurements': [{'value': '620', 'spread': '196', 'groupId': 'OG000'}, {'value': '620', 'spread': '196', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo 1st Then Sitagliptin', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period'}, {'id': 'FG001', 'title': 'Sitagliptin First Then Placebo', 'description': 'sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.'}], 'periods': [{'title': 'First Intervention (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout Period (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '2nd Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Matching Placebo 1st', 'description': 'Matching Placebo for Sitagliptin\n\nPlacebo: Matching placebo in appearance given once/day orally'}, {'id': 'BG001', 'title': 'Sitagliptin 1st', 'description': '100mg pill, PO administered once daily.\n\nsitagliptin: 100 mg pill, administered once/day orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '10', 'groupId': 'BG000'}, {'value': '63', 'spread': '9', 'groupId': 'BG001'}, {'value': '63', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Non-Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HgA1C', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'BG000'}, {'value': '76', 'spread': '8', 'groupId': 'BG001'}, {'value': '74', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '131', 'spread': '13', 'groupId': 'BG000'}, {'value': '136', 'spread': '15', 'groupId': 'BG001'}, {'value': '134', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '11', 'groupId': 'BG000'}, {'value': '78', 'spread': '20', 'groupId': 'BG001'}, {'value': '75', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '165', 'spread': '31', 'groupId': 'BG000'}, {'value': '169', 'spread': '29', 'groupId': 'BG001'}, {'value': '167', 'spread': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '12', 'groupId': 'BG000'}, {'value': '56', 'spread': '20', 'groupId': 'BG001'}, {'value': '55', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low Density Lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '29', 'groupId': 'BG000'}, {'value': '84', 'spread': '26', 'groupId': 'BG001'}, {'value': '84', 'spread': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '126', 'spread': '53', 'groupId': 'BG000'}, {'value': '138', 'spread': '40', 'groupId': 'BG001'}, {'value': '132', 'spread': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '16.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '15.6', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose', 'classes': [{'categories': [{'measurements': [{'value': '117', 'spread': '26', 'groupId': 'BG000'}, {'value': '134', 'spread': '31', 'groupId': 'BG001'}, {'value': '126', 'spread': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Homeostatic Assessment of Insulin Resistance', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '30', 'groupId': 'BG000'}, {'value': '28', 'spread': '23', 'groupId': 'BG001'}, {'value': '29', 'spread': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Aminotransferase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '17', 'groupId': 'BG000'}, {'value': '25', 'spread': '13', 'groupId': 'BG001'}, {'value': '25', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alkaline Phosphatase', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '10', 'groupId': 'BG000'}, {'value': '78', 'spread': '20', 'groupId': 'BG001'}, {'value': '78', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of Hypertension', 'classes': [{'title': 'With Hypertension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Without Hypertension', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of High Cholesterol', 'classes': [{'title': 'With Dyslipidemia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Without Dyslipidemia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Past or Current', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ACE Inhibitor', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Beta-Blocker', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HMG CoA-Reductase', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2013-05-17', 'resultsFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-29', 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial Artery Flow Mediated Dilation', 'timeFrame': 'Change before and after a single dose (2 hours post) and 8 weeks after daily dosing', 'description': 'A measurement of endothelial function in humans'}], 'secondaryOutcomes': [{'measure': 'Circulating Inflammatory Marker ICAM-1', 'timeFrame': 'Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication'}, {'measure': 'Circulating Inflammatory Markers VCAM-1', 'timeFrame': 'Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dipeptidyl peptidase-4 inhibitor', 'endothelium, vascular', 'diabetes type 2', 'nitric oxide', 'inflammation'], 'conditions': ['Diabetes', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '28145158', 'type': 'DERIVED', 'citation': 'Widlansky ME, Puppala VK, Suboc TM, Malik M, Branum A, Signorelli K, Wang J, Ying R, Tanner MJ, Tyagi S. Impact of DPP-4 inhibition on acute and chronic endothelial function in humans with type 2 diabetes on background metformin therapy. Vasc Med. 2017 Jun;22(3):189-196. doi: 10.1177/1358863X16681486. Epub 2017 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4 inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2 diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this double blinded cross over study where they will receive a sitagliptin pill once a day for 8 weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods are divided by a 4 week period. Blood vessel function will be measured by ultrasound before and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment with each. Blood will also be taken to measure blood markers of inflammation at each time the ultrasounds are performed.', 'detailedDescription': 'We plan to recruit 38 patients with T2DM for this single center, double blind randomized, interventional crossover trial comparing sitagliptin (100 mg/day) to matching placebo. We have chosen placebo over a comparator for this study as our goal is to determine whether sitagliptin both improves glycemic control and endothelial function, properties not shared by other popular classes of agents like sulfonylureas. Subjects will be randomized with a 1:1 allocation ratio to either sitagliptin 1st or placebo 1st.\n\nThe study have 5 total visits. Subjects who pass a phone screen will be invited to a screening visit for study eligibility (Visit 1) Informed consent will be reviewed; a unique study number will be assigned once written informed consent is obtained (no subject will be assigned more than 1 allocation number); relevant participant medical history will be recorded including currently prescribed medications; anthropometric measurements will be taken (height, weight, and waist circumference in metric units) and blood pressure will be recorded (measured in triplicate and averaged). Subjects will be allowed to take their blood pressure medication on the morning of their screening visit, but not the mornings of any of the other study visits to limit the acute influence of these medications on endothelial function. If the potential participant qualifies for the study, he/she will be randomized either to receive sitagliptin 1st (100 mg/day) or matching placebo. Prior to receiving either of set of pills, subjects will return to the study center within approximately 1-2 weeks of the screening visit to undergo initial tests of endothelial function and receive their pills. Prior to all study visits except screening, subjects will also be asked to refrain from any vigorous physical activity (no weight lifting, jogging or any activity vigorous than walking) 24 hours to reduce the risk of fasting hypoglycemia during the study visits. Subjects will also be asked to fast for 6-8 hours prior to the visit to limit the acute dietary influences on vascular endothelial function. At Visit 2, endothelial function will determined by brachial artery reactivity testing prior to and following a single dose of 100 mg of sitagliptin or matching placebo depending on the arm to which the subject was randomized. Blood samples will also be taken at this visit for systemic measurements of endothelial cell activation/inflammation (VCAM-1 and ICAM-1) prior to and 2 hours following acute drug administration. These will be measured at the indicated time points using commercially available kits.\n\nEndothelial function, like the blood samples, will be measured just prior to medication administration and then 2 hours following medication administration by brachial artery reactivity testing as described in Section D.3. The 2 hour time from was chose in given the plasma levels of sitagliptin appear to peak 2 hours following dose administration.32 At the end of this visit, subjects will be given a 9 week supply of the study pills (sitagliptin or matching placebo) as dispensed by the Froedtert Hospital Investigational Pharmacy, and scheduled to return for Visit 3 approximately 8 weeks following Visit 2. Subjects will be asked to not take any study medication for the 24 hours prior to Visit 3. At Visit 3, subjects will undergo repeat testing of endothelial function. Following this study visit, subjects will remain off study pills until they return for Visit 4 approximately 4 weeks following Visit 3. Visit 4 repeats Visit 2 except subjects will receive the set of pills to which they had been randomized to receive second. Subjects will return to the study center for Visit 5 approximately 8 weeks after Visit 4. Visit 5 is identical to Visit 3. Subject adherence will be determined by pill counts performed by MCW Translational Research Unit nursing staff who will perform all pill accounting. All medication dispensation will be handled by the Froedtert Hospital Investigational Drug Pharmacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult age 21-70 years of age.\n2. Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.\n3. On stable metformin therapy for at least 6 weeks prior to enrollment.\n4. Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%.\n\nExclusion Criteria:\n\n1. History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 50% on angiography or by confirmed history of myocardial infarction by standard criteria.)\n2. Evidence of other evident major illness including chronic renal insufficiency (creatinine clearance less than 60 mL/min),chronic liver disease (AST or ALT greater than 2.5 x normal), or cancer currently undergoing systemic therapy or had systemic therapy for cancer within 1 year of enrollment.\n3. Pregnancy as determined by urinary beta-HCG test\n4. Illicit drug use (heroin, cocaine etc) in the past 1 year.\n5. Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman\n6. History of allergy to DPP-4 inhibitors at the time of screening/enrollment\n7. Prior history of pancreatitis\n8. Patients currently on insulin or sulfonylurea therapy.\n9. Patients currently on digoxin.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01859793', 'briefTitle': 'Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'A Randomized, Crossover Design Study of Acute and Chronic Effects of Sitagliptin on Endothelial Function in Humans With Type 2 Diabetes on Background Metformin', 'orgStudyIdInfo': {'id': 'Merck-50600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Matching Placebo for Sitagliptin', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': '100mg pill, PO administered once daily.', 'interventionNames': ['Drug: sitagliptin']}], 'interventions': [{'name': 'sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': '100 mg pill, administered once/day orally', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo in appearance given once/day orally', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Michael E Widlansky, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data set may be shared in a de-identified manner by request from qualified investigators with appropriate qualifications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Michael E. Widlansky', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}