Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00143520
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes
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': 'C521549', 'term': 'rivoglitazone'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], '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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c'}], 'secondaryOutcomes': [{'measure': 'FPG, Lipids, hsCRP, Adiponectin'}]}, 'conditionsModule': {'keywords': ['Placebo and active control dose response study of rivoglitazone in type 2 diabetics'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20370378', 'type': 'DERIVED', 'citation': 'Truitt KE, Goldberg RB, Rosenstock J, Chou HS, Merante D, Triscari J, Wang AC. A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. Curr Med Res Opin. 2010 Jun;26(6):1321-31. doi: 10.1185/03007991003715079.'}]}, 'descriptionModule': {'briefSummary': 'This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes in male or female patients\n* Between 18 and 75 years of age\n* With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization\n\nExclusion Criteria:\n\n* Type 1 diabetics or type 2 diabetics currently on insulin therapy\n* Patients unwilling or unable to discontinue their anti-diabetic medication(s)\n* History of ketoacidosis\n* History of therapy with rosiglitazone, troglitazone, pioglitazone'}, 'identificationModule': {'nctId': 'NCT00143520', 'briefTitle': 'Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CS0011-203'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivoglitazone', 'type': 'DRUG'}, {'name': 'Pioglitazone', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Columbiana', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.17817, 'lon': -86.60721}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'city': 'Sherwood', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.81509, 'lon': -92.22432}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Moreno Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'city': 'West Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Cocoa Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.32055, 'lon': -80.60922}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Warner Robins', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.61574, 'lon': -83.62664}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'city': 'Clinton', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.51561, 'lon': -98.96731}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'city': 'Conroe', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.31188, 'lon': -95.45605}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Midland', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.99735, 'lon': -102.07791}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Spring', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.07994, 'lon': -95.41716}}, {'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}, {'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical monitor', 'oldOrganization': 'Daiichi Sankyo'}}}}