Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00857558
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2009-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2009-03-04', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in HbA1C from baseline', 'timeFrame': '2w, 4w, 8w, 12w, 16w'}], 'secondaryOutcomes': [{'measure': 'values and changes in HbA1c form baseline', 'timeFrame': '2w, 4w, 8w, 12w, 16w'}, {'measure': 'values and changes in fasting blood glucose (FSB) from baseline', 'timeFrame': '2w, 4w, 8w, 12w, 16w'}, {'measure': 'adverse event', 'timeFrame': 'at any time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes, Type 2']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes patients with HbA1c above 7.0% and below 10%\n* Patients who are capable of giving informed consent\n* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner\n\nExclusion Criteria:\n\n* Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus\n* Patients with a medical history of diabetes coma\n* Patients with poorly-controlled hypertension\n* Patients with heart failure\n* Patients with a complication of active hepatitis or hepatic cirrhosis\n* Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy\n* Patients with a history or complication of malignant tumor"}, 'identificationModule': {'nctId': 'NCT00857558', 'briefTitle': 'A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '262-08-001'}, 'secondaryIdInfos': [{'id': 'JapicCTI-090697', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'OPC-262 1mg', 'interventionNames': ['Drug: saxagliptin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'OPC-262 2.5mg', 'interventionNames': ['Drug: saxagliptin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'OPC-262 5mg', 'interventionNames': ['Drug: saxagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'saxagliptin', 'type': 'DRUG', 'description': 'orally administration at 1 mg once a day for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'saxagliptin', 'type': 'DRUG', 'description': 'orally administration at 2.5 mg once a day for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'saxagliptin', 'type': 'DRUG', 'description': 'orally administration at 5 mg once a day for 12 weeks', 'armGroupLabels': ['3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'orally administration once a day for 12 weeks', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Regin', 'country': 'Japan'}, {'city': 'Chugoku Region', 'country': 'Japan'}, {'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Katsuhisa Saito', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OPC-J'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}