Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-28 @ 5:01 PM
Study NCT ID:
NCT00237250
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2005-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2005-10-09', 'studyFirstSubmitQcDate': '2005-10-09', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in area under the 0-2 hour prandial glucose curve at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse event profile after 12 weeks of treatment'}, {'measure': 'Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment'}, {'measure': 'Change in HOMA B at 12 weeks'}, {'measure': 'Change in fasting insulin at 12 weeks'}, {'measure': 'Change in fasting proinsulin/insulin ratio at 12 weeks'}]}, 'conditionsModule': {'keywords': ['Pre-diabetes', 'vildagliptin', 'IGT'], 'conditions': ['Prediabetic State']}, 'referencesModule': {'references': [{'pmid': '17947341', 'type': 'DERIVED', 'citation': 'Rosenstock J, Foley JE, Rendell M, Landin-Olsson M, Holst JJ, Deacon CF, Rochotte E, Baron MA. Effects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose tolerance. Diabetes Care. 2008 Jan;31(1):30-5. doi: 10.2337/dc07-1616. Epub 2007 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blood glucose criteria must be met\n* Body mass index (BMI) in the range 23-45\n\nExclusion Criteria:\n\n* Diagnosis of diabetes\n* Serious cardiovascular events within the past 6 months\n* Use of insulin or any oral antidiabetic agent\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00237250', 'briefTitle': 'Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance', 'orgStudyIdInfo': {'id': 'CLAF237A2357'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vildagliptin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}