Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01426802
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2011-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-08-30', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of vildagliptin 50 mg bid', 'timeFrame': '12 weeks', 'description': 'Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety.'}]}, 'conditionsModule': {'keywords': ['metformin', 'vildagliptin', 'T2DM'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who sign the informed consent\n* HbA1c in the range of \\> 7 to ≤10.5% at Visit 1\n* Ability to comply with all study requirements\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Serious cardiovascular disorders\n* Liver/renal disease or dysfunction\n* Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin\n* Laboratories values abnormalities as defined by the protocol'}, 'identificationModule': {'nctId': 'NCT01426802', 'briefTitle': 'Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin', 'orgStudyIdInfo': {'id': 'CLAF237AEG01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin 50 bid', 'interventionNames': ['Drug: vildagliptin']}], 'interventions': [{'name': 'vildagliptin', 'type': 'DRUG', 'description': 'Drug 50mg vildagliptin bid', 'armGroupLabels': ['Vildagliptin 50 bid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Investigative site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}