Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01242202
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2010-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
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': 'C572941', 'term': 'ipragliflozin'}, {'id': 'D065089', 'term': 'Glycoside Hydrolase Inhibitors'}, {'id': 'D020909', 'term': 'Acarbose'}, {'id': 'C045621', 'term': 'miglitol'}, {'id': 'C102817', 'term': 'voglibose'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2012-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c', 'timeFrame': 'baseline and 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in fasting plasma glucose', 'timeFrame': 'baseline and 52 weeks'}, {'measure': 'Change from baseline in fasting serum insulin', 'timeFrame': 'baseline and 52 weeks'}, {'measure': 'Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)', 'timeFrame': 'for 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'alpha glucosidase inhibitor', 'ASP1941', 'long-term safety'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=102', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.', 'detailedDescription': 'This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients receiving with α-glucosidase inhibitor mono-therapy for at least 4 weeks\n* HbA1c value between 6.5 and 9.5%\n* Body Mass Index (BMI) 20.0 - 45.0 kg/m2\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus patients\n* Serum creatinine \\> upper limit of normal\n* Proteinuria (albumin/creatinine ratio \\> 300mg/g)\n* Dysuria and/or urinary tract infection, genital infection\n* Significant renal, hepatic or cardiovascular diseases\n* Severe gastrointestinal diseases'}, 'identificationModule': {'nctId': 'NCT01242202', 'briefTitle': 'A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With an α-Glucosidase Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With an α-Glucosidase Inhibitor Alone', 'orgStudyIdInfo': {'id': '1941-CL-0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP group', 'description': 'Concomitant administration of ASP1941 and α- glucosidase inhibitor', 'interventionNames': ['Drug: ipragliflozin', 'Drug: alpha glucosidase inhibitor']}], 'interventions': [{'name': 'ipragliflozin', 'type': 'DRUG', 'otherNames': ['ASP1941'], 'description': 'oral', 'armGroupLabels': ['ASP group']}, {'name': 'alpha glucosidase inhibitor', 'type': 'DRUG', 'otherNames': ['Acarbose', 'Miglitol', 'Voglibose'], 'description': 'oral', 'armGroupLabels': ['ASP group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 44.62026, 'lon': 142.29986}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}