Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00728351
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2008-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2013-01-02', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-07-31', 'dispFirstSubmitQcDate': '2013-01-02', 'studyFirstSubmitQcDate': '2008-08-04', 'dispFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'FPG reduction', 'timeFrame': '24 weeks'}, {'measure': 'Safety and tolerability', 'timeFrame': '24 weeks'}, {'measure': 'Body weight change from baseline', 'timeFrame': '24 weeks'}, {'measure': 'Changes in the fasting lipid profile', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes, vildagliptin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com', 'label': 'Click here for more information on the clinical study'}, {'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3860', 'label': 'Results for CLMF237A2309 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of T2DM treated with Metformin\n\nExclusion Criteria:\n\n* FPG \\>= 260 mg/dL (14.4mmol/L)\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00728351', 'briefTitle': 'Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.', 'orgStudyIdInfo': {'id': 'CLMF237A2309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vildagliptin + metformin', 'interventionNames': ['Drug: vildagliptin + metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin', 'interventionNames': ['Drug: metformin']}], 'interventions': [{'name': 'vildagliptin + metformin', 'type': 'DRUG', 'armGroupLabels': ['vildagliptin + metformin']}, {'name': 'metformin', 'type': 'DRUG', 'description': '1000 bid metformin', 'armGroupLabels': ['metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71603', 'city': 'Pine Bluff', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.22843, 'lon': 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