Viewing Study NCT00359112

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Ignite Creation Date: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
Study NCT ID: NCT00359112
Status: COMPLETED
Last Update Posted: 2009-05-18
First Post: 2006-07-28
Is NOT Gene Therapy: False
Has Adverse Events: False
Brief Title: AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'C471074', 'term': 'rosiglitazone-metformin combination'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-15', 'studyFirstSubmitDate': '2006-07-28', 'studyFirstSubmitQcDate': '2006-07-31', 'lastUpdatePostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c level from baseline following 52 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in FPG (fasting plasma glucose)'}, {'measure': 'insulin sensitivity'}, {'measure': 'beta cell function'}, {'measure': 'change in PAI-1'}, {'measure': 'CRP'}, {'measure': 'number of hypoglycaemic events'}, {'measure': 'Change in 24 hr ABPM'}, {'measure': 'Diabetes treatment satisfaction.'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'overweight', 'AVANDAMET', 'metformin', 'sulphonylurea'], 'conditions': ['Non-Insulin-Dependent Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Body mass index \\> or = to 25 kg/m2.\n* HbA1c \\> or =7% and \\< or =10% at screening.\n* FPG \\> or = 7.0mmol/L (126mg/dL) at visit 2.\n* Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.\n* Female subjects must be postmenopausal or using effective contraceptive measures.\n\nExclusion criteria:\n\n* Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.\n* Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.\n* Subjects with a history of severe hypoglycaemia.\n* Renal disease or renal dysfunction.\n* Presence of clinically significant hepatic disease.\n* Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.\n* Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT00359112', 'briefTitle': 'AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.', 'orgStudyIdInfo': {'id': 'AVM100264'}}, 'armsInterventionsModule': {'interventions': [{'name': 'metformin', 'type': 'DRUG'}, {'name': 'sulphonylurea', 'type': 'DRUG'}, {'name': 'Avandamet', 'type': 'DRUG', 'otherNames': ['metformin', 'sulphonylurea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1030', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1210', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '5020', 'city': 'Champion', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.4953, 'lon': 4.90385}}, {'zip': '3001', 'city': 'Heverlee', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.86426, 'lon': 4.69597}}, {'zip': '3400', 'city': 'Landen', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.75267, 'lon': 5.082}}, {'zip': '3945', 'city': 'Oostham', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.10374, 'lon': 5.17877}}, {'zip': '4800', 'city': 'Petit-Rechain', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.61489, 'lon': 5.83417}}, {'zip': '2243', 'city': 'Pulle', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.20317, 'lon': 4.71434}}, {'zip': '3980', 'city': 'Tessenderlo', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.06513, 'lon': 5.08856}}, {'zip': '3120', 'city': 'Tremelo', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.99231, 'lon': 4.70807}}, {'zip': '2830', 'city': 'Willebroek', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.06041, 'lon': 4.36019}}, {'zip': '59100', 'city': 'Roubaix', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '59410', 'city': 'Anzin', 'country': 'France', 'facility': 'GSK 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