Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00241605
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2005-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AVANDAMET Versus Metformin For 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': 'C471074', 'term': 'rosiglitazone-metformin combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06-25'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2005-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2005-10-17', 'studyFirstSubmitQcDate': '2005-10-17', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c at week 48.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'AVANDAMET', 'Type 2 diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).\n* Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.\n* Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.\n\nExclusion Criteria:\n\n* Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.\n* Have a known hypersensitivity to thiazolidinediones or biguanides.\n* Currently using insulin or any oral anti-diabetic agent other than metformin.\n* History of metabolic acidosis.\n* History of substance abuse.\n* Have active cancer other than localized squamous or basal cell carcinoma.\n* Chronic disease requiring treatment with corticosteroids.\n* Other criteria will be evaluated at the screening visit.'}, 'identificationModule': {'nctId': 'NCT00241605', 'briefTitle': 'AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.', 'orgStudyIdInfo': {'id': '712753/008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rosiglitazone/metformin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T1Y 3R6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T1Y 6J2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2A 0P9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2L 2V9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T3B 0M3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T3E 0C5', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T3E 7C4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5A 4L8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 6K3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T1A 6N9', 'city': 'Medicine Hat', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.03928, 'lon': -110.67661}}, {'zip': 'V4W 3L6', 'city': 'Aldergrove', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.05801, 'lon': -122.47087}}, {'zip': 'V1Y 3G8', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V5P 3T7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5X 3T5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V7N 4M2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R2H 0R8', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 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-63.57688}}, {'zip': 'B2N 1L2', 'city': 'Truro', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.36685, 'lon': -63.26538}}, {'zip': 'B3Z 4R4', 'city': 'Upper Tantallon', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.68781, 'lon': -63.87781}}, {'zip': 'L1S 6N2', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L6T 3T1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L6T 4S5', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L7M 4Y1', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 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{'zip': 'J0L 1E0', 'city': 'Sainte-Catherine', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.40008, 'lon': -73.58248}}, {'zip': 'G1V 1V6', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'zip': 'G0R 3E0', 'city': 'Sainte-Henri de Levis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site'}, {'zip': 'J6S 4Z5', 'city': 'Salaberry-de-Valleyfield', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.25008, 'lon': -74.13253}}, {'zip': 'G6G 6H1', 'city': 'Thetford-Mines', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.09371, 'lon': -71.30539}}, {'zip': 'J7V 8P9', 'city': 'Vaudreuil', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site'}, {'zip': 'H8N 1X9', 'city': 'Ville 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'responsibleParty': {'type': 'SPONSOR'}}}}