Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-26 @ 9:30 PM
Study NCT ID:
NCT00396357
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2006-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
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': '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': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 914}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-12-28', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2006-11-02', 'dispFirstSubmitQcDate': '2012-12-28', 'studyFirstSubmitQcDate': '2006-11-03', 'dispFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse event profile after 24 weeks of treatment', 'timeFrame': '24 weeks'}, {'measure': 'Gastrointestinal tolerability after 24 weeks of treatment', 'timeFrame': '24 weeks'}, {'measure': 'Patients with endpoint HbA1c <7% and <6.5% after 24 weeks', 'timeFrame': '24 weeks'}, {'measure': 'Patients with reduction in HbA1c >0.7% after 24 weeks', 'timeFrame': '24 weeks'}, {'measure': 'Change from baseline in fasting plasma glucose after 24 weeks', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'vildagliptin', 'hemoglobin A1c', 'metformin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2654', 'label': 'Results for CLAF237A23104 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-78 years inclusive\n* Type 2 diabetes diagnosis at least 2 months prior to study entry\n* Body mass index in the range of 22-45 kg/m2\n* HbA1c in the range of 6.5 to 9% inclusive\n* Fasting plasma glucose \\<270 mg/dL (15 mmol/L)\n\nExclusion Criteria:\n\n* A history of type 1 diabetes\n* Evidence of significant diabetic complications\n* Treatment with insulin or any other oral antidiabetic agents\n* Congestive heart failure requiring pharmacologic treatment\n* Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \\>/= 1.5 mg/dl (males) and \\>/= 1.4 mg/dl (females)\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00396357', 'briefTitle': 'Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy', 'orgStudyIdInfo': {'id': 'CLAF237A23104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vildagliptin + metformin', 'interventionNames': ['Drug: Vildagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'interventionNames': ['Drug: metformin']}], 'interventions': [{'name': 'Vildagliptin', 'type': 'DRUG', 'armGroupLabels': ['vildagliptin + metformin']}, {'name': 'metformin', 'type': 'DRUG', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'city': 'Multiple Locations', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}