Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 6:28 AM
Study NCT ID:
NCT00351832
Status:
COMPLETED
Last Update Posted:
2007-05-09
First Post:
2006-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Compare the Effect of Vildagliptin Compared to Placebo 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'}], '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': {'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-07', 'studyFirstSubmitDate': '2006-07-11', 'studyFirstSubmitQcDate': '2006-07-11', 'lastUpdatePostDateStruct': {'date': '2007-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on HbA1c at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on fasting plasma glucose at 12 weeks'}, {'measure': 'Change from baseline on HOMA B at 12 weeks'}, {'measure': 'Change from baseline on HOMA IR at 12 weeks'}, {'measure': 'Change from baseline in body weight at 12 weeks'}, {'measure': 'Change from baseline on fasting lipids at 12 weeks'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Vildagliptin', 'Hemoglobin A1c'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes\n* Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control\n* Outpatients\n\nExclusion Criteria:\n\n* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes\n* Significant cardiovascular disease\n* Significant diabetic complications\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00351832', 'briefTitle': 'A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CLAF237A1303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vildagliptin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}