Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00334503
Status:
COMPLETED
Last Update Posted:
2008-10-10
First Post:
2006-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
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': 'C045621', 'term': 'miglitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2008-10-08', 'studyFirstSubmitDate': '2006-06-05', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['alpa-glucosidase inhibitor,Biguanide'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients with Biguanide treatment\n* Criteria for postprandial plasma glucose and HbA1c are met\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Patients treated with other antidiabetic drugs or Insulin'}, 'identificationModule': {'nctId': 'NCT00334503', 'briefTitle': 'Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanwa Kagaku Kenkyusho Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'MG1009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Miglitol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gunma', 'country': 'Japan'}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'overallOfficials': [{'name': 'Clinical Study Group, Clinical Development Dept.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanwa Kagaku Kenkyusho Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanwa Kagaku Kenkyusho Co., Ltd.', 'class': 'INDUSTRY'}}}}