[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597040":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":54,"centralContacts":58,"locations":66,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":28,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":28,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":69,"whyStopped":28,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin plus Pioglitazone placebo","EXPERIMENTAL","Empagliflozin 25 mg\u002Fday plus pioglitazone placebo",[13],"Drug: Empagliflozin 25 MG plus Pioglitazone placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Pioglitazone plus Empagliflozin Placebo","PLACEBO_COMPARATOR","Pioglitazone, 15 mg\u002Fday, increased to 30 mg after 2 weeks plus empagliflozin placebo",[19],"Drug: Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Empagliflozin plus Pioglitazone","Empagliflozin(25mg\u002Fday) plus pioglitazone (15\u002F30 mg\u002Fd)",[24],"Drug: Empagliflozin 25 mg\u002Fd plus Pioglitazone (15\u002F30 mg\u002Fd)",{"label":26,"type":10,"description":27,"interventionNames":28},"Empagliflozin placebo + pioglitazone placebo","empagliflozin placebo plus pioglitazone placebo",null,[30,38,44,50],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Empagliflozin 25 MG plus Pioglitazone placebo","A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.",[9],[36,37],"Empagliflozin","Placebo-Inert tablet",{"type":31,"name":39,"description":37,"armGroupLabels":40,"otherNames":41},"Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo",[15],[42,43],"Placebo for empagliflozin","Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications",{"type":31,"name":45,"description":43,"armGroupLabels":46,"otherNames":47},"Empagliflozin 25 mg\u002Fd plus Pioglitazone (15\u002F30 mg\u002Fd)",[21],[48,49],"Empagliflozin\u002FPioglitazone","Empagliflozin, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.",{"type":31,"name":51,"description":37,"armGroupLabels":28,"otherNames":52},"Pioglitazone placebo + Empagliflozin placebo",[53],"Placebo\u002FPlacebo",[55],{"name":56,"affiliation":5,"role":57},"Ralph DeFronzo, MD","PRINCIPAL_INVESTIGATOR",[59,63],{"name":56,"role":60,"phone":61,"phoneExt":28,"email":62},"CONTACT","210-567-6691","defronzo@uthscsa.edu",{"name":64,"role":60,"phone":61,"phoneExt":28,"email":65},"Aurora Merovci, MD","merovci@uthscsa.edu",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Texas Diabetes Institute\u002FUH","RECRUITING","San Antonio","Texas","78229-3900","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-98.49363,29.42412,{"lat":79,"lon":78},[82,84,85],{"name":56,"role":60,"phone":83,"phoneExt":28,"email":62},"210-358-7200",{"name":64,"role":60,"phone":61,"phoneExt":28,"email":65},{"name":56,"role":57,"phone":28,"phoneExt":28,"email":28},{"type":87,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[89],{"name":90,"class":91},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100597040","phase-1-sglt2i-pioglitazone-and-ketone-production-in-t2d-100597040",false,"NCT07053319","SGLT2i, Pioglitazone, and Ketone Production in T2D","Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus","Patients with T2D\n\nInclusion Criteria:\n\n* Ages 30-75 years\n* Body Mass Index (BMI) 21-45 kg\u002Fm2\n* Hemoglobin A1C (HbA1c) = 7.0-11%\n* Estimated glomerular filtration rate (eGFR) \\> 60 ml\u002Fmin\u002F1.73m2\n* Blood Pressure (BP) \\\u003C 145\u002F85 mmHg\n* Participants must be in general good health based on medical history, physical exam, screening blood chemistries, complete blood chemistry (CBC), thyroid stimulating hormone\u002Fthyroxine (TSH\u002FT4), electrocardiogram (EKG), and urinalysis\n* Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program\n* Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU\u002FMET\n* Statin therapy is permissible if the dose has been stable for at least 3 months\n\nExclusion Criteria:\n\n* Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded\n* Patients taking medications (other than SU\u002FMET) known to affect glucose metabolism are excluded\n* Subjects with evidence of proliferative retinopathy or eGFR \\\u003C 60 are excluded\n* Women of childbearing potential are excluded unless they are taking\u002Fusing appropriate contractive medications\u002Fdevices","ALL","30 Years","75 Years",{"count":103,"type":104},64,"ESTIMATED","INTERVENTIONAL",[107],"PHASE1","To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).",[110],"Type 2 Diabetes",[112,113,114,115],"Endogenous glucose production","Ketogenesis","Gluconeogenesis","Lipolysis","2026-05-11",{"date":118,"type":119},"2026-05-12","ACTUAL",{"date":116,"type":119},{"date":122,"type":104},"2027-06-30",{"name":5,"class":6},1]