Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 10:36 PM
Study NCT ID:
NCT02048904
Status:
TERMINATED
Last Update Posted:
2017-08-10
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Sitagliptin to Decrease Microalbuminuria
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': 'lastrag@health.missouri.edu', 'phone': '573-882-2273 lastrag@healt', 'title': 'Principal Investigator', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was terminated during the enrollment period due to difficulties at the study site. 65 participants had completed study by time of study termination.No data were collected or analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin or Placebo', 'description': '100 mg/day for 3 months or 1 pill/day for 3 months\n\nSitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Microalbuminuria Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin or Placebo', 'description': '100 mg/day for 3 months or 1 pill/day for 3 months\n\nSitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months'}], 'timeFrame': 'Six months', 'description': 'Decrease in microalbuminuria level', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin or Placebo', 'description': '100 mg/day for 3 months or 1 pill/day for 3 months\n\nSitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}]}]}], 'recruitmentDetails': 'Total enrollment at time of termination of study was 142 participants. However, study was terminated during the enrollment period due to difficulties at the study site. All data collected from participants remains untabulated and no analysis is expected.', 'preAssignmentDetails': '65 participants had completed study by time of study termination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin or Placebo', 'description': '100 mg/day for 3 months or 1 pill/day for 3 months\n\nSitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 - 75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Total enrollment was 142 participants, with 65 completing. However, data was not analyzed and results are unavailable as investigator and study coordinator no longer work at the institution and did not make information available. Study was terminated prematurely.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Total enrollment was 142 participants, with 65 completing. However, data was not analyzed and results are unavailable as investigator and study coordinator no longer work at the institution and did not make information available. Study was terminated prematurely.'}], 'populationDescription': 'Total enrollment was 142 participants, with 65 completing, 7 withdrew voluntarily, and 70 were found to be ineligible. However, data was not analyzed and results are unavailable as investigator and study coordinator no longer work at the institution and did not make information available. Study was terminated prematurely.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'whyStopped': 'Original Principal Investigator left institution. No data analyzed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2014-01-27', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-11', 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Microalbuminuria Level', 'timeFrame': 'Six months', 'description': 'Decrease in microalbuminuria level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microalbuminuria', 'type 2 diabetes'], 'conditions': ['Type 2 Diabetes', 'Microalbuminuria']}, 'descriptionModule': {'briefSummary': 'The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.\n\nThis study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it will reduce protein levels in their urine. Protein levels in the urine are a marker of the severity of kidney disease.', 'detailedDescription': 'The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an ACE inhibitor or ARB. However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Albumin/creatinine ratio between 30-299 mg/dl.\n* type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.\n* Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three months prior and during the trial.\n* Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.\n* Age between 18-75 years old.\n* For women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (OCP), intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.\n\nExclusion Criteria:\n\n* Pregnancy.\n* GFR less than 60 mL/min/73m2.\n* Have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to Visit 1.\n* Advanced liver disease.\n* Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least 4 months before the study start.\n* Psychiatric condition that would prevent subject from following directions. Per PI discretion.'}, 'identificationModule': {'nctId': 'NCT02048904', 'briefTitle': 'Use of Sitagliptin to Decrease Microalbuminuria', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease', 'orgStudyIdInfo': {'id': '1207397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': '100 mg/day for 3 months', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 pill/day for 3 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Sitagliptin 100 mg/day for 3 months', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 1 pill/day for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia: Diabetes Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Guido Lastra Gonzalez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}