Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT01046318
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2010-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of OPC-262 in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2010-01-06', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)', 'timeFrame': 'each visit (OC) and Week 52 (LOCF)'}, {'measure': 'Clinical laboratory tests', 'timeFrame': 'every 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)', 'timeFrame': 'each visit (OC) and Week 52 (LOCF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination\n2. Patients who are capable of giving informed consent\n3. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus\n2. Patients with a medical history of diabetic coma\n3. Patients with poorly-controlled hypertension\n4. Patients with heart failure\n5. Patients with a complication of active hepatitis or hepatic cirrhosis\n6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy\n7. Patients with a history or complication of malignant tumor"}, 'identificationModule': {'nctId': 'NCT01046318', 'briefTitle': 'A Study of OPC-262 in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Long-term Study of OPC-262 in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '262-09-004'}, 'secondaryIdInfos': [{'id': 'JapicCTI-090952', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPC-262 5 mg', 'description': 'OPC-262 5 mg will be orally administered once daily fro 52 weeks.', 'interventionNames': ['Drug: OPC-262']}], 'interventions': [{'name': 'OPC-262', 'type': 'DRUG', 'description': 'OPC-262 5 mg will be orally administered once daily fro 52 weeks.', 'armGroupLabels': ['OPC-262 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}