[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581138":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard","ACTIVE_COMPARATOR","Metformin therapy",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental","EXPERIMENTAL","Empagliflozin therapy",[19],"Drug: Empagliflozin 10 mg",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Empagliflozin 10 mg","The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin.",[15],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Metformin",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Ji Young Byun Administrative staff, MS","CONTACT","82-31-787-7035","65423@snubh.org",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"SNUBH","RECRUITING","Seongnam","South Korea",{"type":43,"coordinates":44},"Point",[45,46],127.7548,36.4052,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":26,"email":52},"Soo Lim, MD.","82-10-9766-2706","limsoo@snu.ac.kr",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Soo Lim","Professor","100581138","phase-4-the-empa-fit-study-100581138",false,"NCT06846411","The EMPA-FIT Study","Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes","EMPA-FIT","Inclusion Criteria:\n\n* Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.\n\nExclusion Criteria:\n\n* individuals with a body mass index (BMI) \\\u003C18.5 kg\u002Fm² or ≥40 kg\u002Fm², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²) or end-stage renal disease (eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis) were also excluded.\n\nAdditional exclusion criteria included uncontrolled hypertension (BP ≥160\u002F100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (\\>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides \\>1,000 mg\u002FdL or LDL cholesterol \\>250 mg\u002FdL).","ALL","20 Years",{"count":68,"type":69},46,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg\u002Fday) or metformin (1,000 mg\u002Fday) for 12 weeks.",[75,76],"Diabetes","Diabetes Mellitus, Type II",[78],"Metformin, empagliflozin, glucose variability","2025-02-20",{"date":81,"type":82},"2025-02-26","ACTUAL",{"date":84,"type":82},"2024-01-01",{"date":86,"type":69},"2025-12-31",{"name":5,"class":6},1]