Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 1:20 PM
Study NCT ID:
NCT01224366
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c reduction', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'HbA1c reduction in subpopulation treated with insulin and with metformin', 'timeFrame': '24 weeks'}, {'measure': 'HbA1c reduction in subpopulation treated with insulin and without metformin', 'timeFrame': '24 weeks'}, {'measure': 'Reduction in FPG (overall and subpopulations)', 'timeFrame': '24 weeks'}, {'measure': 'Responder rates (overall and subpopulations)', 'timeFrame': '24 weeks'}, {'measure': 'Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['Add-on to insulin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23961326', 'type': 'RESULT', 'citation': 'Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of T2DM\n* On a stable dose of insulin as defined by the protocol\n* On a stable does of metformin (if applicable) as defined by the protocol\n* Age 18 to 80 years\n* HbA1c of 7.5 to 11.0%\n* Body Mass Index (BMI) 22 to 40 kg/m2\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Short-acting or rapid-acting insulin\n* Pregnancy or lactation\n* Evidence of serious diabetic complications\n* Evidence of serious cardiovascular complications\n* Laboratory value abnormalities as defined by the protocol\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01224366', 'briefTitle': 'Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'CLAF237A23135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'interventionNames': ['Drug: Vildagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vildagliptin', 'type': 'DRUG', 'armGroupLabels': ['Vildagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Box Hill', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'city': 'Heidelberg Heights', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.74313, 'lon': 145.05695}}, {'city': 'Parkville', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Wollongong', 'country': 'Australia', 'facility': 'Novartis Investigative Site #1', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Wollongong', 'country': 'Australia', 'facility': 'Novartis Investigative Site #2', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'Novartis 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