Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 3:51 PM
Study NCT ID:
NCT00102466
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2005-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
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': 'D005907', 'term': 'Gliclazide'}, {'id': 'D008687', 'term': 'Metformin'}], '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': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'dispFirstSubmitDate': '2013-01-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2005-01-29', 'dispFirstSubmitQcDate': '2013-01-02', 'studyFirstSubmitQcDate': '2005-01-28', 'dispFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c at 52 weeks', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse event profile after 52 weeks of treatment', 'timeFrame': '52 weeks'}, {'measure': 'Change from baseline in fasting plasma glucose at 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Patients with endpoint HbA1c <7% at 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Patients with reduction in HbA1c >/= 0.7% after 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Patients with reduction in HbA1c >/= 0.5% after 52 weeks', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'vildagliptin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2851', 'label': 'Results for CLAF237A2338 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On a stable dose of metformin as defined by the protocol\n* Blood glucose criteria must be met\n* Body mass index (BMI) in the range 22-45\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Type 1 diabetes\n* Evidence of significant diabetic complications\n* Evidence of serious cardiovascular complications\n* Laboratory value abnormalities as defined by the protocol\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00102466', 'briefTitle': 'Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CLAF237A2338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'interventionNames': ['Drug: vildagliptin', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gliclazide', 'interventionNames': ['Drug: Gliclazide', 'Drug: Metformin']}], 'interventions': [{'name': 'vildagliptin', 'type': 'DRUG', 'armGroupLabels': ['Vildagliptin']}, {'name': 'Gliclazide', 'type': 'DRUG', 'armGroupLabels': ['Gliclazide']}, {'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['Gliclazide', 'Vildagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Investigative Centers', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}