Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:34 AM
Study NCT ID:
NCT00865592
Status:
TERMINATED
Last Update Posted:
2010-08-11
First Post:
2009-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552164', 'term': 'dutogliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-10', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate safety and tolerability of dutogliptin', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'To demonstrate maintenance or lowering of HbA1c', 'timeFrame': 'Two years'}, {'measure': 'To demonstrate maintenance or lowering of fasting blood glucose', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'DPP4 inhibitor', 'dutogliptin', 'PHX1149'], 'conditions': ['Type 2 Diabetes Mellitus', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.', 'detailedDescription': 'In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)\n* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301\n\nExclusion Criteria:\n\n* Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat\n* Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment"}, 'identificationModule': {'nctId': 'NCT00865592', 'briefTitle': 'Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenomix'}, 'officialTitle': 'An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PHX1149-PROT300E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dutogliptin', 'type': 'DRUG', 'otherNames': ['PHX1149T', 'PHX1149', 'dutogliptin tartrate'], 'description': 'dutogliptin 400 mg, once daily tablet'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Phenomix Investigational Site 663', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 103', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 110', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 111', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 106'}, {'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 112', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'city': 'Paraná', 'country': 'Argentina', 'facility': 'Phenomix Investigational Site 102', 'geoPoint': {'lat': -31.73271, 'lon': -60.52897}}, {'city': 'Bangalore, Karnataka', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Chennai, Tamil Nadu', 'country': 'India', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Gulbarga, Karnataka', 'country': 'India', 'geoPoint': {'lat': 17.33583, 'lon': 76.83757}}, {'city': 'Hyderabad, Andhara Pradesh', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Mumbai, Maharashtra', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Nagpur, Maharashtra', 'country': 'India', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'city': 'Nashik, Maharashtra', 'country': 'India', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'city': 'Navi Mumbai, Maharashtra', 'country': 'India', 'geoPoint': {'lat': 19.03681, 'lon': 73.01582}}, {'city': 'Pune, Maharashtra', 'country': 'India', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Phenomix Investigational Site 403', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'city': 'Kelantan', 'country': 'Malaysia'}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Perak', 'country': 'Malaysia', 'geoPoint': {'lat': 3.8682, 'lon': 102.5862}}, {'city': 'Putrajaya', 'country': 'Malaysia', 'facility': 'Phenomix Investigational Site 404', 'geoPoint': {'lat': 2.93527, 'lon': 101.69112}}, {'city': 'Sarawak', 'country': 'Malaysia'}, {'city': 'Arequipa', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 604', 'geoPoint': {'lat': -16.39899, 'lon': -71.53747}}, {'city': 'Lambayeque', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 606', 'geoPoint': {'lat': -6.70111, 'lon': -79.90611}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 600', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 601', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 602', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Phenomix Investigational Site 609', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Cebu City', 'country': 'Philippines', 'facility': 'Phenomix Investigational Site 703', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Manila, NCR', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Quezon City, NCR', 'country': 'Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'San Juan, NCR', 'country': 'Philippines', 'geoPoint': {'lat': 14.6, 'lon': 121.0333}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 802', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 806', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 800', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 803', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 805', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 807', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Galati', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 804', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Ploieşti', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 801', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Phenomix Investigational Site 808', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 551', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 550', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 557', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 564', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 555', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 556', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 562', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 563', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kylv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 554'}, {'city': 'Lutsk', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 565', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 553', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 561', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'city': 'Simferopol', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 560', 'geoPoint': {'lat': 44.95719, 'lon': 34.11079}}, {'city': 'Vinnitsa', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 559', 'geoPoint': {'lat': 49.84639, 'lon': 37.71861}}, {'city': 'Zaporzhzhia', 'country': 'Ukraine', 'facility': 'Phenomix Investigational Site 552'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenomix', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Hans-Peter Guler, MD', 'oldOrganization': 'Phenomix'}}}}