[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583351":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":28,"locations":29,"responsibleParty":46,"collaborators":28,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":28,"enrollmentInfo":58,"targetDuration":28,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":32,"whyStopped":28,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Dong Wha Pharmaceutical Co. Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dasidiem 10\u002F100mg","EXPERIMENTAL","Dapagliflozin 10mg +sitagliptin 100mg combination drug",[13],"Drug: DW6012(Dasidiem tab. 10\u002F100mg)",{"label":15,"type":16,"description":17,"interventionNames":18},"sitdiem 100mg, Piotazone15mg","ACTIVE_COMPARATOR","sitagliptin 100mg, Pioglitazone 15mg",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","DW6012(Dasidiem tab. 10\u002F100mg)","Once a day, Oral administration",[9,15],[26,27],"Piotazone tab.","Sitdiem tab. 100mg",null,[30],{"facility":31,"status":32,"city":33,"state":28,"zip":28,"country":34,"countryCode":28,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Kyung Hee University Hospital at Gangdong","RECRUITING","Seoul","South Korea",{"type":36,"coordinates":37},"Point",[38,39],126.9784,37.566,{"lat":39,"lon":38},[42],{"name":31,"role":43,"phone":44,"phoneExt":28,"email":45},"CONTACT","82+2-440-7000","cri@khnmc.or.kr",{"type":47,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100583351","phase-4-dm-treatment-to-evaluate-the-efficacy-and-safety-of-dapagliflozin-or-pioglitazone-in-patients-with-type-2-diabetes-100583351",false,"NCT06875193","DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes","Key Finding of DM Treatment with Combination, a MuLticenter, Randomized, Parallel, Gathering Information of Phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes","KLIMT","Inclusion Criteria:\n\n* Patients with type 2 diabetes who are 19 years of age or older at the date of written consent\n* Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening\n* HbA1c ≤ 7.0% ≤ HbA1c \\\u003C 10% at time of screening\n* BMI ≤ 18.5 kg\u002Fm2 ≤ 40 kg\u002Fm2 at time of screening\n* Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes\n* Have a BMI \\> 40 kg\u002Fm2\n* Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n* Patients with end stage renal disease or patients on dialysis\n* Patients with uncontrolled heart failure (NYHA class III - IV)\n* Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit\n* Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis\n* Patients with diabetic coma or precoma\n* Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors.\n* Patients with hematuria\n* Patients who receiving treatment for thyroid dysfunction at the time of screening\n* Malnourished, starving, or debilitated subjects\n* Patients with pituitary insufficiency or adrenal insufficiency\n* Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal\n* Patients with severe infectious diseases, perioperative, or clinically significant trauma\n* Have a history of substance abuse\n* Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit\n* Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids\n* Patients with a history of malignancy within the last 5 years\n* Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied\n* Pregnant and breastfeeding women\n* Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients\n* Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption.\n* Any other person deemed by the investigator to be unsuitable for participation in the study","ALL","19 Years",{"count":59,"type":60},196,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)",[66],"Type2diabetes",[68,69,70],"Dapagliflozin","Pioglitazone","DPP-4 inhibitor","2025-03-12",{"date":73,"type":74},"2025-03-17","ACTUAL",{"date":76,"type":74},"2024-05-28",{"date":78,"type":60},"2025-12-31",{"name":5,"class":6},1]