[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100294883":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":45,"centralContacts":50,"locations":51,"responsibleParty":104,"collaborators":50,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":50,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":50,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":129,"whyStopped":130,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ipragliflozin and metformin","EXPERIMENTAL","Subjects will receive daily dosage of ipragliflozin and metformin as single tablets",[13,14],"Drug: metformin","Drug: ipragliflozin",{"label":16,"type":10,"description":17,"interventionNames":18},"glimepiride and metformin","Subjects will receive daily dosage of glimepiride and metformin as single tablets",[13,19],"Drug: glimepiride",[21,34,40],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","metformin","oral",[16,9],[27,28,29,30,31,32,33],"Fortamet","Riomet","Glucophage","Diabex XR","Glumetza","Diabex","Glucophage XR",{"type":22,"name":35,"description":24,"armGroupLabels":36,"otherNames":37},"ipragliflozin",[9],[38,39],"ASP1941","Suglat",{"type":22,"name":41,"description":24,"armGroupLabels":42,"otherNames":43},"glimepiride",[16],[44],"Amaryl",[46],{"name":47,"affiliation":48,"role":49},"Medical Monitor","Astellas Pharma Korea, Inc.","STUDY_DIRECTOR",null,[52,62,65,73,81,86,91,96],{"facility":53,"status":50,"city":54,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":56,"geoPoint":61,"contacts":50},"Site 13","Busan","South Korea",{"type":57,"coordinates":58},"Point",[59,60],129.03004,35.10168,{"lat":60,"lon":59},{"facility":63,"status":50,"city":64,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":50,"geoPoint":50,"contacts":50},"Site 02","Deagu",{"facility":66,"status":50,"city":67,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":50},"Site 11","Guri-si",{"type":57,"coordinates":69},[70,71],127.1394,37.5986,{"lat":71,"lon":70},{"facility":74,"status":50,"city":75,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":76,"geoPoint":80,"contacts":50},"Site 01","Seoul",{"type":57,"coordinates":77},[78,79],126.9784,37.566,{"lat":79,"lon":78},{"facility":82,"status":50,"city":75,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":83,"geoPoint":85,"contacts":50},"Site 05",{"type":57,"coordinates":84},[78,79],{"lat":79,"lon":78},{"facility":87,"status":50,"city":75,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":88,"geoPoint":90,"contacts":50},"Site 07",{"type":57,"coordinates":89},[78,79],{"lat":79,"lon":78},{"facility":92,"status":50,"city":75,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":93,"geoPoint":95,"contacts":50},"Site 09",{"type":57,"coordinates":94},[78,79],{"lat":79,"lon":78},{"facility":97,"status":50,"city":98,"state":50,"zip":50,"country":55,"countryCode":50,"cosmosGeoPoint":99,"geoPoint":103,"contacts":50},"Site 12","Suwon",{"type":57,"coordinates":100},[101,102],127.00889,37.29111,{"lat":102,"lon":101},{"type":105,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100294883","phase-4-a-study-to-evaluate-the-renal-protective-effect-urine-albumin-to-creatinine-ratio-uacr-efficacy-and-safety-of-ipragliflozin-in-type-2-diabetes-mellitus-patients-with-albuminuria-100294883",false,"NCT03118713","A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria","A Phase 4, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Renal Protective Effect (UACR), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria","Inclusion Criteria:\n\nInclusion Criteria assessed at Visit 1:\n\n* Subject who is outpatient.\n* Subject who has been diagnosed with type 2 diabetes mellitus.\n* Subject who has been on a stable dose of at least 1000 mg\u002Fday metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1.\n* Subject who has an HbA1C value between 7.0% and 9.0% at Visit 1.\n* Subject who has a urinary albumin\u002Fcreatinine ratio greater than or equal to 30 mg\u002Fg at Visit 1.\n* Subject who has eGFR greater than or equal to 45 mL\u002Fmin\u002F1.73 m\\^2.\n* Subject is on stable diet and exercise program for at least 8 weeks (56 days) prior to Visit 1.\n\nInclusion Criterion assessed at Visit 2:\n\n* Subject who has a urinary albumin\u002Fcreatinine ratio greater than or equal to 30 mg\u002Fg at Visit 2.\n\nExclusion Criteria:\n\n* Subject who has been diagnosed with type 1 diabetes mellitus.\n* Subject who started or has changed the types and\u002For dosage of Renin Angiotensin System (RAS) inhibitors (Angiotensin II Receptor Blockers (ARBs), ACE inhibitors) within 12 weeks prior to Visit 1.\n* Subject who has been treated with Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors within 12 weeks prior to Visit 1.\n* Subject who has a history of clinically significant renal disease(s) (other than diabetic nephropathy) such as renovascular occlusive disease, nephrectomy, or renal transplant.\n* Subject who has a diabetic ketoacidosis, or history of diabetic ketoacidosis.\n* Subject with diabetic coma or precoma.\n* Subject with severe infection, serious trauma, or perioperative subject at Visit 1\n* Subject who has a history of hypersensitivity to ipragliflozin or glimepiride or other SGLT-2 inhibitors or sulfonylureas.\n* Subject has Aspartate Aminotransferase (GOT) (AST) or Alanine Aminotransferase (GPT) (ALT) value exceeding 3 times of upper limit of the normal range, or total bilirubin value exceeding 3 times of upper limit of the normal range at Visit 1.\n* Subject has progressive proliferative diabetic retinopathy.\n* Subject has a symptomatic urinary tract infection or genital infection at Visit 1.\n* Subject has uncontrollable psychiatric disorder(s) with medication.\n* Subject abuses drug or alcohol at Visit 1.\n* Subject has lactic acidosis or has history of lactic acidosis.\n* Subject who has been known to have Hepatitis B, Hepatitis C or Positive Human immunodeficiency virus (HIV).\n* Subject is unable or unwilling to adhere to any of the protocol requirements such as hospital visits and dose instruction specified in this study.\n* Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.\n* Subject has participated in another interventional study with study drugs within 12 weeks prior to obtaining written informed consent.\n* Subject has a clinical condition which would not allow safe conduct of the study.","ALL","19 Years","74 Years",{"count":117,"type":118},33,"ACTUAL","INTERVENTIONAL",[121],"PHASE4","The primary purpose of this study is to assess the renal protective effect of ipragliflozin in combination with metformin on the percent change of UACR from baseline to 24 weeks against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria.",[124],"Type 2 Diabetes Mellitus",[126,127,124,38,128],"Metformin","Ipragliflozin","Glimepiride","TERMINATED","Business decision due to enrollment challenges","2024-11-07",{"date":133,"type":118},"2024-11-08",{"date":135,"type":118},"2017-04-25",{"date":137,"type":118},"2018-12-12",{"name":48,"class":6},8]