[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580514":3},{"organization":4,"outcomesModule":7,"designInfo":79,"detailedDescription":83,"studyPopulation":84,"armGroups":85,"interventions":105,"overallOfficials":80,"centralContacts":119,"locations":125,"responsibleParty":141,"collaborators":80,"id":143,"slug":80,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":151,"maxAge":80,"enrollmentInfo":152,"targetDuration":80,"studyType":155,"phases":80,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":128,"whyStopped":80,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.","Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration).","24 month",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Changes in HbA1c","Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group","3, 6, (9), 12, 18, and 24 months",{"measure":19,"description":20,"timeFrame":17},"Changes in FPG","Evaluation of FPG(mg\u002FdL) Change Compared to Baseline in Each Combination Group",{"measure":22,"description":23,"timeFrame":17},"Percentage of Subjects with HbA1c \u003C 7.0%","Percentage of Subjects with HbA1c \\\u003C 7.0% in Each Combination Group",{"measure":25,"description":26,"timeFrame":17},"Percentage of Subjects with HbA1c \u003C 6.5%","Percentage of Subjects with HbA1c \\\u003C 6.5% in Each Combination Group",{"measure":28,"description":29,"timeFrame":12},"Factors influencing HbA1c change at each endpoint for each combination group.","demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.",[31,35,39,43,46,49,52,55,58,61,64,67,70,73,76],{"measure":32,"description":33,"timeFrame":34},"Changes in Weight","Changes in Weight(kg) Compared to Baseline in Each Combination Group","3, 6, (9), 12, 18, 24 months",{"measure":36,"description":37,"timeFrame":38},"Changes in waist circumference","Changes in waist circumference(cm) compared to Baseline in Each Combination Group (body composition in body water(L), protein(kg), minerals(kg), and body fat(kg))","12 and 24 months",{"measure":40,"description":41,"timeFrame":42},"Changes in Fatty Liver Index","Changes in Fatty Liver Index compared to Baseline in Each Combination Group","6, 12, 18, and 24 months",{"measure":44,"description":45,"timeFrame":42},"Changes in AST","Changes in AST(IU\u002FL) Compared to Baseline in Each Combination Group",{"measure":47,"description":48,"timeFrame":42},"Changes in ALT","Changes in ALT(IU\u002FL) Compared to Baseline in Each Combination Group",{"measure":50,"description":51,"timeFrame":42},"Changes Platelet Levels","Changes in Platelet(10\\^3\u002FuL) Levels Compared to Baseline in Each Combination Group",{"measure":53,"description":54,"timeFrame":42},"Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG)","Change in Total cholesterol, LDL-C, HDL-C, TG(mg\u002FdL) compared to Baseline in Each Combination Group",{"measure":56,"description":57,"timeFrame":38},"Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β)","Changes in HOMA-IR(%), HOMA-(%) compared to Baseline in Each Combination Group",{"measure":59,"description":60,"timeFrame":38},"Changes in eGFR","Changes in eGFR(mL\u002Fmin\u002F1.73m2) compared to Baseline in Each Combination Group",{"measure":62,"description":63,"timeFrame":38},"Changes in UACR","Changes in UACR(mg\u002Fg) compared to Baseline in Each Combination Group",{"measure":65,"description":66,"timeFrame":38},"Change in hsCRP","Change in hsCRP(mg\u002FdL) compared to Baseline in Each Combination Group",{"measure":68,"description":69,"timeFrame":38},"Change in ProBNP(or NT-ProBNP)","Change in ProBNP(or NT-ProBNP)(pg\u002FmL) compared to Baseline in Each Combination Group",{"measure":71,"description":72,"timeFrame":17},"Change in PP2 Compared to Baseline in Each Combination Group","Change in PP2(mg\u002FdL) compared to Baseline in Each Combination Group.",{"measure":74,"description":75,"timeFrame":12},"Incidence Rate of Major Adverse Cardiovascular Events(MACE)","Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group",{"measure":77,"description":78,"timeFrame":12},"Incidence Rate of Diabetic Microvascular Events","Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group",{"allocation":80,"interventionModel":80,"interventionModelDescription":80,"primaryPurpose":80,"observationalModel":81,"timePerspective":82,"maskingInfo":80},null,"COHORT","PROSPECTIVE","The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.\n\nParticipants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.\n\nThe 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.","Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.",[86,92,97,101],{"label":87,"type":80,"description":88,"interventionNames":89},"Metformin\u002FDPP4i\u002FSGLT2i","Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.",[90,91],"Drug: SGLT2 inhibitor","Drug: DPP-4 inhibitor",{"label":93,"type":80,"description":94,"interventionNames":95},"Metformin\u002FDPP4i\u002FTZD","Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.",[96,91],"Drug: Thiazolidinedione",{"label":98,"type":80,"description":99,"interventionNames":100},"Metformin\u002FSGLT2i\u002FDPP4i","Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.",[90,91],{"label":102,"type":80,"description":103,"interventionNames":104},"Metformin\u002FSGLT2i\u002FTZD","Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.",[90,96],[106,111,115],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":80},"DRUG","SGLT2 inhibitor","SGLT2 inhibitor class of drugs",[87,98,102],{"type":107,"name":112,"description":113,"armGroupLabels":114,"otherNames":80},"Thiazolidinedione","Thiazolidinedione class of drugs",[93,102],{"type":107,"name":116,"description":117,"armGroupLabels":118,"otherNames":80},"DPP-4 inhibitor","DPP4 inhibitor class of drugs",[87,93,98],[120],{"name":121,"role":122,"phone":123,"phoneExt":80,"email":124},"Soo Lim, M.D, Ph.D.","CONTACT","82-2-6373-0773","limsoo@snu.ac.kr",[126],{"facility":127,"status":128,"city":129,"state":130,"zip":80,"country":131,"countryCode":80,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Seoul National University Bundang Hospital","RECRUITING","Seongnam-si","Gyeonggi-do","South Korea",{"type":133,"coordinates":134},"Point",[135,136],127.13778,37.43861,{"lat":136,"lon":135},[139],{"name":121,"role":122,"phone":140,"phoneExt":80,"email":124},"1588-3369",{"type":142,"investigatorFullName":80,"investigatorTitle":80,"investigatorAffiliation":80,"oldNameTitle":80,"oldOrganization":80},"SPONSOR","100580514",false,"NCT06838286","Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes","A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients","TRIO","Inclusion Criteria:\n\n1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.\n2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.\n3. 7.0% ≤ HbA1c \\\u003C 10.0% based on laboratory tests performed within 4 weeks of enrollment.\n4. Voluntarily give written informed consent after being told about the study.\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes and secondary diabetes.\n2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.\n3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.\n4. End-stage renal disease and hemodialysis patients.\n5. diabetic ketoacidosis Patients.\n6. Pregnant and lactating women.\n7. Patients who are contraindicated by any of the \"Precautions for Use\" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.\n8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.\n9. Anyone else deemed by the investigator to be unsuitable for participation in the study.","ALL","19 Years",{"count":153,"type":154},10000,"ESTIMATED","OBSERVATIONAL","A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.",[158],"Diabetes Mellitus, Type 2",[160,161,162,163],"Type 2 diabetes mellitus","Korean patients","Observational study","OAD triple therapy","2025-02-18",{"date":166,"type":167},"2025-02-20","ACTUAL",{"date":169,"type":167},"2024-03-16",{"date":171,"type":154},"2029-12-31",{"name":5,"class":6},1]