Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00461058
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria']}, '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': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2007-04-16', 'studyFirstSubmitQcDate': '2007-04-16', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.', 'timeFrame': '26 week'}], 'secondaryOutcomes': [{'measure': 'Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.', 'timeFrame': '26 week'}, {'measure': 'Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.', 'timeFrame': '26 week'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. 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'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* type 2 diabetes for \\>=1 month;\n* drug naive, or receiving stable doses of \\<=2 oral antihyperglycemic medications;\n* HbA1c 6.5-10.0% at screening;\n* symptomatic, stable NYHA class 2 heart failure at screening.\n\nExclusion Criteria:\n\n* type 1 diabetes;\n* current or previous treatment with insulin;\n* uncontrolled hypertension;\n* NYHA class 1, 3 or 4 at screening.'}, 'identificationModule': {'nctId': 'NCT00461058', 'briefTitle': 'A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.', 'orgStudyIdInfo': {'id': 'BC20265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Actos', 'interventionNames': ['Drug: Actos']}, {'type': 'EXPERIMENTAL', 'label': 'Aleglitazar', 'interventionNames': ['Drug: aleglitazar']}], 'interventions': [{'name': 'Actos', 'type': 'DRUG', 'description': 'Titrated to an individual maximum tolerated dose up to 45mg p.o. daily', 'armGroupLabels': ['Actos']}, {'name': 'aleglitazar', 'type': 'DRUG', 'description': 'Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily', 'armGroupLabels': ['Aleglitazar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '70458', 'city': 'Slidell', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.27519, 'lon': -89.78117}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': 'SIN80020', 'city': 'Culiacán', 'country': 'Mexico', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': 'JAL44340', 'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': 'EMEX52140', 'city': 'Metepec', 'country': 'Mexico', 'geoPoint': {'lat': 19.25934, 'lon': -99.60175}}, {'zip': '11650', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': 'DF7060', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64000', 'city': 'Monterrey', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '42000', 'city': 'Pachuca', 'country': 'Mexico', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}, {'zip': 'SLP78250', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '310037', 'city': 'Arad', 'country': 'Romania', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '600114', 'city': 'Bacau', 'country': 'Romania', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'zip': '430123', 'city': 'Baia Mare', 'country': 'Romania', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '010242', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '20475', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '50452', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '410169', 'city': 'Oradea', 'country': 'Romania', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '100097', 'city': 'Ploieşti', 'country': 'Romania', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '130083', 'city': 'Târgovişte', 'country': 'Romania', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'zip': '123436', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125101', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127018', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127299', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '191025', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198205', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '199106', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '83003', 'city': 'Donetsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '83114', 'city': 'Donetsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61178', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '02091', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '1151', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '2091', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}