[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597040":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":26,"studyPopulation":13,"armGroups":27,"interventions":48,"overallOfficials":73,"centralContacts":77,"locations":85,"responsibleParty":105,"collaborators":107,"id":111,"slug":13,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":13,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":13,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":88,"whyStopped":13,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Endogenous Glucose Production (EGP)","Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion).","0 and 300 minutes",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","A randomized controlled 4 arm clinical trial","BASIC_SCIENCE",{"masking":20,"maskingDescription":21,"whoMasked":22},"TRIPLE","Subjects will be randomly assigned 1:1:1:1 ratio",[23,24,25],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Participants: 64 T2D subjects with the same inclusion and exclusion criteria as Protocol 1. Subjects with hematuria are excluded.\n\nStudy Design: Infusions of 3-3H-glucose and 14C-glycerol are started and continued to study end (2 PM). Baseline blood samples for HbA1c (x2) and for plasma insulin, glucagon, glucose, FFA, BHB, AcAc, glycerol, and plasma 3-3H-glucose and 14C-glycerol specific activities are drawn at -30, -20, -10, -5, and 0 minutes for measurement of lipolysis, ketone production (plasma ketone levels), and EGP. Empagliflozin (25 mg) is ingested at time zero (9AM) and plasma samples for the above are obtained every 10-20 minutes.\n\nFollowing completion of the above study, subjects will be randomized to one of four groups (16 per group) for 10 weeks: (1) empagliflozin, 25 mg\u002Fday, plus pioglitazone placebo; (2) pioglitazone, 15 mg\u002Fday, increased to 30 mg after 2 weeks plus empagliflozin placebo; (3) empagliflozin (25 mg\u002Fd) plus pioglitazone (15\u002F30 mg\u002Fd); (4) empa placebo plus pio placebo. Subjects will return to the CRC every 1-2 weeks for interim medical history, to check medication compliance, and to measure plasma insulin, glucagon, glucose, FFA, glycerol, BHB, and AcAc levels. At week 10, subjects will return to the CRC at 6AM and the baseline study will be repeated. HbA1c will be measured twice during week 10.",[28,34,40,45],{"label":29,"type":30,"description":31,"interventionNames":32},"Empagliflozin plus Pioglitazone placebo","EXPERIMENTAL","Empagliflozin 25 mg\u002Fday plus pioglitazone placebo",[33],"Drug: Empagliflozin 25 MG plus Pioglitazone placebo",{"label":35,"type":36,"description":37,"interventionNames":38},"Pioglitazone plus Empagliflozin Placebo","PLACEBO_COMPARATOR","Pioglitazone, 15 mg\u002Fday, increased to 30 mg after 2 weeks plus empagliflozin placebo",[39],"Drug: Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo",{"label":41,"type":30,"description":42,"interventionNames":43},"Empagliflozin plus Pioglitazone","Empagliflozin(25mg\u002Fday) plus pioglitazone (15\u002F30 mg\u002Fd)",[44],"Drug: Empagliflozin 25 mg\u002Fd plus Pioglitazone (15\u002F30 mg\u002Fd)",{"label":46,"type":30,"description":47,"interventionNames":13},"Empagliflozin placebo + pioglitazone placebo","empagliflozin placebo plus pioglitazone placebo",[49,57,63,69],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"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.",[29],[55,56],"Empagliflozin","Placebo-Inert tablet",{"type":50,"name":58,"description":56,"armGroupLabels":59,"otherNames":60},"Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo",[35],[61,62],"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":50,"name":64,"description":62,"armGroupLabels":65,"otherNames":66},"Empagliflozin 25 mg\u002Fd plus Pioglitazone (15\u002F30 mg\u002Fd)",[41],[67,68],"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":50,"name":70,"description":56,"armGroupLabels":13,"otherNames":71},"Pioglitazone placebo + Empagliflozin placebo",[72],"Placebo\u002FPlacebo",[74],{"name":75,"affiliation":5,"role":76},"Ralph DeFronzo, MD","PRINCIPAL_INVESTIGATOR",[78,82],{"name":75,"role":79,"phone":80,"phoneExt":13,"email":81},"CONTACT","210-567-6691","defronzo@uthscsa.edu",{"name":83,"role":79,"phone":80,"phoneExt":13,"email":84},"Aurora Merovci, MD","merovci@uthscsa.edu",[86],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Texas Diabetes Institute\u002FUH","RECRUITING","San Antonio","Texas","78229-3900","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-98.49363,29.42412,{"lat":98,"lon":97},[101,103,104],{"name":75,"role":79,"phone":102,"phoneExt":13,"email":81},"210-358-7200",{"name":83,"role":79,"phone":80,"phoneExt":13,"email":84},{"name":75,"role":76,"phone":13,"phoneExt":13,"email":13},{"type":106,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[108],{"name":109,"class":110},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","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":121,"type":122},64,"ESTIMATED","INTERVENTIONAL",[125],"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).",[128],"Type 2 Diabetes",[130,131,132,133],"Endogenous glucose production","Ketogenesis","Gluconeogenesis","Lipolysis","2026-05-11",{"date":136,"type":137},"2026-05-12","ACTUAL",{"date":134,"type":137},{"date":140,"type":122},"2027-06-30",{"name":5,"class":6},1]