Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-09 @ 9:52 AM
Study NCT ID:
NCT00980356
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2009-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vildagliptin in New Onset Diabetes After Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2009-09-18', 'studyFirstSubmitQcDate': '2009-09-18', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start compared to placebo.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To assess differences in the change in HbA1c and fasting plasma glucose after 3 months after treatment start and to assess the safety and efficacy of Vildagliptin in renal transplanted patients.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Kidney transplantation', 'New onset diabetes mellitus after transplantation'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32803882', 'type': 'DERIVED', 'citation': 'Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.'}, {'pmid': '24279801', 'type': 'DERIVED', 'citation': 'Haidinger M, Werzowa J, Hecking M, Antlanger M, Stemer G, Pleiner J, Kopecky C, Kovarik JJ, Doller D, Pacini G, Saemann MD. Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation--a randomized, double-blind, placebo-controlled trial. Am J Transplant. 2014 Jan;14(1):115-23. doi: 10.1111/ajt.12518. Epub 2013 Nov 26.'}, {'pmid': '20925938', 'type': 'DERIVED', 'citation': 'Haidinger M, Werzowa J, Voigt HC, Pleiner J, Stemer G, Hecking M, Doller D, Horl WH, Weichhart T, Saemann MD. A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation. Trials. 2010 Oct 6;11:91. doi: 10.1186/1745-6215-11-91.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed New Onset Diabetes after Transplantation (NODAT).', 'detailedDescription': 'Development of new onset diabetes mellitus after transplantation (NODAT) also called post-transplant diabetes mellitus (PTDM) increases the risk of cardiovascular disease and poor short term clinical outcomes. There is currently no doubt about the fact that NODAT is a condition that needs medical attention and treatment. Although most centers follow treatment regimens for DM type II prospective data about their effectiveness in NODAT are lacking. Little information exists in kidney transplantation regarding conventional glucose-lowering therapies, either oral hypoglycemic agents or traditional insulin regimens. The Aim of this study was to evaluate whether a monotherapy with Vildagliptin improve glycemic control and to assess the safety in kidney transplanted patients with newly diagnosed NODAT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose): glucose ≥ 200mg/dl\n\n* renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of triple therapy with tacrolimus or cyclosporine A, mycophenolate mofetil or azathioprine, and prednisone.\n* stable graft function for more than 6 months post transplant.\n* informed consent of the patient\n\nExclusion Criteria:\n\n* patients with prior history of type 1 or type 2 diabetes\n* body mass index (BMI) \\> 40\n* pregnancy\n* severe renal impairment (GFR \\< 30 mL/min./1.73 m2)\n* severe liver impairment\n* severe blood glucose elevation with the need for therapy with insulin or HbA1c \\>8.5%'}, 'identificationModule': {'nctId': 'NCT00980356', 'acronym': 'VINODAT', 'briefTitle': 'Vildagliptin in New Onset Diabetes After Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Vildagliptin in New Onset Diabetes After Transplantation - A Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'EudraCT: 2009-14405-14'}, 'secondaryIdInfos': [{'id': 'EK645/2009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vildagliptin, 50 mg, peroral', 'interventionNames': ['Drug: Vildagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill'}], 'interventions': [{'name': 'Vildagliptin', 'type': 'DRUG', 'description': 'Patients receive once daily 50 mg Vildagliptin', 'armGroupLabels': ['Vildagliptin, 50 mg, peroral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Marcus D Säemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Marcus Säemann', 'investigatorFullName': 'Marcus Saemann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}