Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00316758
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, '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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2006-04-20', 'studyFirstSubmitQcDate': '2006-04-20', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs, laboratory parameters, ECG.', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Mean change from original baseline in HbA1c, FPG, lipid profile.', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. 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': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetic patients who have completed studies BM18248 or BM18249;\n* patients considered by the investigator to be suitable for long term treatment with GK Activator (2).\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus;\n* women who are pregnant, breast-feeding or not using adequate contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT00316758', 'briefTitle': 'A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249', 'orgStudyIdInfo': {'id': 'NC19794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: GK Activator (2)', 'Drug: Metformin']}], 'interventions': [{'name': 'GK Activator (2)', 'type': 'DRUG', 'description': 'Escalating doses bid', 'armGroupLabels': ['1']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'As prescribed, in patients who were in study BM18249', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '67005', 'city': 'Arkansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.06197, 'lon': -97.03837}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45246', 'city': 'Springdale', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.287, 'lon': -84.48522}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '29464', 'city': 'Mt. 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