Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00138593
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2005-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2005-08-27', 'studyFirstSubmitQcDate': '2005-08-27', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety in combination with pioglitizone after 52 weeks of treatment'}, {'measure': 'Change from baseline in HbA1c at 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in fasting plasma glucose at 52 weeks'}, {'measure': 'Change from baseline in fasting lipids at 52 weeks'}, {'measure': 'Change from baseline in body weight at 52 weeks'}, {'measure': 'Change from baseline in HOMA B at 52 weeks'}, {'measure': 'Change from baseline in HOMA IR at 52 weeks'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'vildagliptin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20518805', 'type': 'RESULT', 'citation': 'Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.'}]}, 'descriptionModule': {'briefSummary': 'This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only patients successfully completing study CLAF237A2329 are eligible\n* Written informed consent\n* HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units\n* Ability to comply with all study requirements\n\nExclusion Criteria:\n\n* Premature discontinuation from study CLAF237A2329\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00138593', 'briefTitle': 'Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%', 'orgStudyIdInfo': {'id': 'CLAF237A2329E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vildagliptin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}