Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 4:16 PM
Study NCT ID:
NCT00036192
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2002-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2002-05-08', 'studyFirstSubmitQcDate': '2002-05-08', 'lastUpdatePostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.', 'detailedDescription': 'This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Has history of type 2 diabetes mellitus for at least 1 year\n* Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched.\n* Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months\n\nExclusion Criteria\n\n* Has type 1 diabetes mellitus\n* Has uncontrolled hypertension, i.e., systolic BP \\>170 or diastolic BP \\> 95 mm Hg.\n* History of congestive heart failure'}, 'identificationModule': {'nctId': 'NCT00036192', 'briefTitle': 'Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea', 'orgStudyIdInfo': {'id': 'FA-614-0004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FK614', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36360', 'city': 'Ozark', 'state': 'Alabama', 'country': 'United States', 'facility': 'International Institute of Clinical Research, Inc.', 'geoPoint': {'lat': 31.45906, 'lon': -85.64049}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'OCCR @ East Gate Medical Center', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials of St. Jude Heritage Md Grp', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Foundation of America', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Diabetes and Endocrine Care', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Physician's Office", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Diabetes Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Diabetes Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Clinical Studies', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Clireco, Inc.', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83651', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'McConnehey Family Medicine', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': "Physician's Office", 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Research, Inc.', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Radiant Research - Minneapolis', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': "Physician's East", 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44260', 'city': 'Mogadorf', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research'}, {'zip': '97232', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Physician's Office", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Physicians for Clinical Research', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '19522', 'city': 'Fleetwood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fleetwood Medical Associates', 'geoPoint': {'lat': 40.45398, 'lon': -75.81798}}, {'zip': '19124', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Founders Research Corp.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '17254', 'city': 'Scotland', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'SFM Clinical Trials', 'geoPoint': {'lat': 39.9687, 'lon': -77.58721}}, {'zip': '37825', 'city': 'New Tazewell', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Heartland Medical PC', 'geoPoint': {'lat': 36.44258, 'lon': -83.59963}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Mercury Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes / Glandular Disease Research Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sam Clinical Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire Research Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99216', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "Physician's Office", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'University Physicians Internal Medicine', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma US, Inc.', 'class': 'INDUSTRY'}]}}}