Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01006018
Status:
TERMINATED
Last Update Posted:
2013-12-05
First Post:
2009-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
DPP-4 Inhibition and TZD for DM Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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': 'D000077205', 'term': 'Pioglitazone'}], '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': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mrhee@emory.edu', 'phone': '404-778-1666', 'title': 'Mary Rhee, M.D.', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin + Pioglitazone PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone PLACEBO daily by mouth', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sitagliptin + Pioglitazone', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone (TZD) 15 mg daily by mouth', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth\n\n\\+ pioglitazone (TZD) PLACEBO daily by mouth', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin + Pioglitazone PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone PLACEBO daily by mouth'}, {'id': 'OG001', 'title': 'Sitagliptin + Pioglitazone', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone (TZD) 15 mg daily by mouth'}, {'id': 'OG002', 'title': 'PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth\n\n\\+ pioglitazone (TZD) PLACEBO daily by mouth'}], 'timeFrame': 'baseline, 6 months, 9 months (after a 3 month washout)', 'description': 'Not measured as study was prematurely terminated due to unanticipated delays.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin + Pioglitazone PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone PLACEBO daily by mouth'}, {'id': 'FG001', 'title': 'Sitagliptin + Pioglitazone', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone (TZD) 15 mg daily by mouth'}, {'id': 'FG002', 'title': 'PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth\n\n\\+ pioglitazone (TZD) PLACEBO daily by mouth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Only 3 control (normal glucose tolerance) subjects were enrolled to obtain results in normal subjects for the hyperglycemic clamp (without GLP-1 or arginine). No samples were run, and, therefore, there are no data for the control subjects.\n\nNo subjects with impaired glucose tolerance (IGT) were recruited or enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin + Pioglitazone PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone PLACEBO daily by mouth'}, {'id': 'BG001', 'title': 'Sitagliptin + Pioglitazone', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone (TZD) 15 mg daily by mouth'}, {'id': 'BG002', 'title': 'PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth\n\n\\+ pioglitazone (TZD) PLACEBO daily by mouth'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'paramType': 'MEAN', 'unitOfMeasure': 'participants', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female'}, {'title': 'Male'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Unanticipated delays due to sterilization/stabilization testing of GLP-1.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2009-10-27', 'resultsFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-01', 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': 'baseline, 6 months, 9 months (after a 3 month washout)', 'description': 'Not measured as study was prematurely terminated due to unanticipated delays.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prediabetic State'], 'conditions': ['Prediabetic State']}, 'referencesModule': {'references': [{'pmid': '33210751', 'type': 'DERIVED', 'citation': 'Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impaired glucose tolerance (IGT) by oral glucose tolerance test\n\nExclusion Criteria:\n\n* History of diabetes mellitus\n* History of congestive heart failure\n* History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)\n* History of liver disease (ALT or AST \\>2.5 times the upper limit of normals)\n* History of renal disease (serum creatinine \\>1.5 mg/dl)\n* History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)\n* Current treatment with glucocorticoids\n* History of immune disorder, including HIV\n* Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures'}, 'identificationModule': {'nctId': 'NCT01006018', 'acronym': 'DInT DM', 'briefTitle': 'DPP-4 Inhibition and TZD for DM Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)', 'orgStudyIdInfo': {'id': 'IRB00015390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin + Pioglitazone PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone PLACEBO daily by mouth', 'interventionNames': ['Drug: Sitagliptin + Pioglitazone PLACEBO']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin + Pioglitazone', 'description': 'Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth\n\n\\+ pioglitazone (TZD) 15 mg daily by mouth', 'interventionNames': ['Drug: Sitagliptin + Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth\n\n\\+ pioglitazone (TZD) PLACEBO daily by mouth', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'Sitagliptin + Pioglitazone PLACEBO', 'type': 'DRUG', 'otherNames': ['Januvia (sitagliptin)', 'Pioglitazone (Actos)'], 'description': 'Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily', 'armGroupLabels': ['Sitagliptin + Pioglitazone PLACEBO']}, {'name': 'Sitagliptin + Pioglitazone', 'type': 'DRUG', 'otherNames': ['Januvia (sitaglitin)', 'Pioglitazone (Actos)'], 'description': 'Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily', 'armGroupLabels': ['Sitagliptin + Pioglitazone']}, {'name': 'PLACEBO', 'type': 'DRUG', 'otherNames': ['Januvia (sitagliptin) PLACEBO', 'Pioglitazone (Actos) PLACEBO'], 'description': 'Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Mary Rhee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Mary Rhee', 'investigatorAffiliation': 'Emory University'}}}}