Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-01 @ 12:32 PM
Study NCT ID:
NCT00361868
Status:
TERMINATED
Last Update Posted:
2008-06-27
First Post:
2006-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000077154', 'term': 'Rosiglitazone'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'whyStopped': 'The study was discontinued prematurely at the end of March 2007 due to slow enrolment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-26', 'studyFirstSubmitDate': '2006-08-08', 'studyFirstSubmitQcDate': '2006-08-08', 'lastUpdatePostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c/TG', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Lipid and glycemic parameters.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus'], 'conditions': ['Dyslipidemia', 'Glucose Metabolism Disorder']}, 'descriptionModule': {'briefSummary': 'Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.\n\nExclusion Criteria:\n\n* Type 1 diabetes.'}, 'identificationModule': {'nctId': 'NCT00361868', 'briefTitle': 'Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia', 'orgStudyIdInfo': {'id': 'C LF23-0121 05 01'}, 'secondaryIdInfos': [{'id': '2005-006060-63'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Rosiglitazone']}], 'interventions': [{'name': 'fenofibrate (F) + metformin (M) hydrochloride fixed combination', 'type': 'DRUG', 'description': 'First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Rosiglitazone', 'type': 'DRUG', 'description': 'First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pula', 'country': 'Croatia', 'facility': 'Site105', 'geoPoint': {'lat': 44.86833, 'lon': 13.84806}}, {'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Site102', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Split', 'country': 'Croatia', 'facility': 'Site103', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'city': 'Varaždin', 'country': 'Croatia', 'facility': 'Site104', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Site100', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Site101', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Jyväskylä', 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