Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-07 @ 7:27 PM
Study NCT ID:
NCT01398592
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2011-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077597', 'term': 'Vildagliptin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2011-07-15', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin', 'timeFrame': '14 days', 'description': 'Fasting Plasma Glucose measured on day 14.'}], 'secondaryOutcomes': [{'measure': 'To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin', 'timeFrame': '14 days', 'description': 'Fasting Plasma Glucose on day 14 analyzed descriptively.'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus Type two', 'T2DM', 'vildagliptin', 'sitagliptin', 'FPG', 'DPP-4'], 'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '25457473', 'type': 'DERIVED', 'citation': 'Goke R, Eschenbach P, Dutting ED. Efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose: Results of a randomized controlled trial. Diabetes Metab. 2015 Jun;41(3):244-7. doi: 10.1016/j.diabet.2014.07.004. Epub 2014 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with type 2 diabetes 18 to 85 years Metformin monotherapy \\> 4 weeks HbA1c 6.5 - 9.5%\n\nExclusion Criteria:\n\nFPG \\> 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)'}, 'identificationModule': {'nctId': 'NCT01398592', 'acronym': 'FPG-VISIT', 'briefTitle': 'Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks', 'orgStudyIdInfo': {'id': 'CLMF237ADE02'}, 'secondaryIdInfos': [{'id': '2011-000518-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'description': 'Experimental', 'interventionNames': ['Drug: Vildagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Active comparator (drug)', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Vildagliptin', 'type': 'DRUG', 'description': '50mg vildagliptin bid', 'armGroupLabels': ['Vildagliptin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': '100mg sitagliptin po qd', 'armGroupLabels': ['Sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32549', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '12347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13597', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14089', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '29221', 'city': 'Celle', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '30165', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30167', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '34117', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '35274', 'city': 'Kirchhain', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.8272, 'lon': 8.92806}}, {'zip': '31275', 'city': 'Lehrte', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37193, 'lon': 9.97919}}, {'zip': '45468', 'city': 'Mülheim', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': '46049', 'city': 'Oberhausen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': '49080', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '14469', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '70378', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Rüdiger Göke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirchhain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}