Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00388518
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Aleglitazar in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'France', 'Serbia and Montenegro']}, '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': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'C542437', 'term': 'aleglitazar'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-06-28', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2006-10-16', 'dispFirstSubmitQcDate': '2016-06-28', 'studyFirstSubmitQcDate': '2006-10-16', 'dispFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change from baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.', 'timeFrame': '16 weeks'}, {'measure': 'Adverse Events (AEs), laboratory parameters.', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '19515415', 'type': 'DERIVED', 'citation': 'Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-75 years of age;\n* type 2 diabetes, diagnosed \\>=1 month of screening;\n* either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;\n* HbA1c \\<=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.\n\nExclusion Criteria:\n\n* type 1 diabetes;\n* currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;\n* clinically significant cardiovascular disease;\n* Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.'}, 'identificationModule': {'nctId': 'NCT00388518', 'briefTitle': 'A Study of Aleglitazar in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'BM17864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Actos', 'interventionNames': ['Drug: Actos']}, {'type': 'EXPERIMENTAL', 'label': 'Aleglitazar 1', 'interventionNames': ['Drug: aleglitazar']}, {'type': 'EXPERIMENTAL', 'label': 'Aleglitazar 2', 'interventionNames': ['Drug: aleglitazar']}, {'type': 'EXPERIMENTAL', 'label': 'Aleglitazar 3', 'interventionNames': ['Drug: aleglitazar']}, {'type': 'EXPERIMENTAL', 'label': 'Aleglitazar 4', 'interventionNames': ['Drug: aleglitazar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Actos', 'type': 'DRUG', 'description': '45mg po daily', 'armGroupLabels': ['Actos']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'po daily', 'armGroupLabels': ['Placebo']}, {'name': 'aleglitazar', 'type': 'DRUG', 'description': 'Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.', 'armGroupLabels': ['Aleglitazar 1', 'Aleglitazar 2', 'Aleglitazar 3', 'Aleglitazar 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85029', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 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