Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:45 AM
Study NCT ID:
NCT01316094
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572941', 'term': 'ipragliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2012-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in Hemoglobin A1c (HbA1c)', 'timeFrame': 'baseline and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'changes in fasting plasma glucose', 'timeFrame': 'baseline and 24 weeks'}, {'measure': 'changes in fasting serum insulin level', 'timeFrame': 'baseline and 24 weeks'}, {'measure': 'changes in eGFR (estimated glomerular filtration rate)', 'timeFrame': 'baseline and 52 weeks'}, {'measure': 'safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs', 'timeFrame': 'for 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'ASP1941', 'Renal impairment'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '31606880', 'type': 'DERIVED', 'citation': 'Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=91', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.', 'detailedDescription': 'This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.\n\nThe severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.\n\nAt 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus patient\n* subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)\n* estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and \\< 90 mL/min/1.73 m2\n* HbA1C value between 6.5 and 8.5%\n* body mass index (BMI) 29.0 - 45.0 kg/m2\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus patients\n* proliferative diabetic retinopathy\n* subject has received insulin within 12 weeks before the study\n* subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic\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': 'NCT01316094', 'briefTitle': 'A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Long-term Study of ASP1941 - Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)', 'orgStudyIdInfo': {'id': '1941-CL-0072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP group', 'description': 'oral', 'interventionNames': ['Drug: ASP1941']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'oral', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['ASP group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'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': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 44.62026, 'lon': 142.29986}}], 'overallOfficials': [{'name': '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'}}}}