[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610485":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":30,"studyPopulation":30,"armGroups":65,"interventions":78,"overallOfficials":87,"centralContacts":91,"locations":97,"responsibleParty":113,"collaborators":30,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":30,"eligibilityCriteria":120,"healthyVolunteers":117,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":30,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":30,"overallStatus":99,"whyStopped":30,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University of Minnesota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Time In Range (TIR) 70- 180 mg\u002FdL","the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment","Month 3",[14,17,19,21,22,24,25,27,28,31,32,34,35,38,39,42,43,46,47,49,50,53,54,57],{"measure":15,"description":16,"timeFrame":12},"Time in Tight Range (TITR) 70-140 mg\u002FdL","from 14 days of home monitoring",{"measure":15,"description":16,"timeFrame":18},"Month 6",{"measure":20,"description":16,"timeFrame":12},"Time in hypoglycemia \u003C70 mg\u002FdL",{"measure":20,"description":16,"timeFrame":18},{"measure":23,"description":16,"timeFrame":12},"Time in hypoglycemia \u003C54 mg\u002FdL",{"measure":23,"description":16,"timeFrame":18},{"measure":26,"description":16,"timeFrame":12},"Time in hyperglycemia >180 mg\u002FdL",{"measure":26,"description":16,"timeFrame":18},{"measure":29,"description":30,"timeFrame":12},"Area under the curve 2 hour glucose from MMTT",null,{"measure":29,"description":30,"timeFrame":18},{"measure":33,"description":30,"timeFrame":12},"Hemoglobin A1c level",{"measure":33,"description":30,"timeFrame":18},{"measure":36,"description":37,"timeFrame":12},"Proinsulin","C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)",{"measure":36,"description":37,"timeFrame":18},{"measure":40,"description":41,"timeFrame":12},"Proportion of patients with ketones >=1.5","Routine home serum ketone testing",{"measure":40,"description":41,"timeFrame":18},{"measure":44,"description":45,"timeFrame":12},"ED\u002F hospital visits for diabetic ketoacidosis (DKA)","number of visits",{"measure":44,"description":45,"timeFrame":18},{"measure":48,"description":30,"timeFrame":12},"Occurrence of urinary or genital tract infection",{"measure":48,"description":30,"timeFrame":18},{"measure":51,"description":52,"timeFrame":12},"Weight change","% weight loss or weight gain",{"measure":51,"description":52,"timeFrame":18},{"measure":55,"description":56,"timeFrame":12},"Diabetes distress","Diabetes Distress Score; Each item is rated on a 6-point scale from (1) \"not a problem\" to (6) \"a very significant problem.\"",{"measure":55,"description":56,"timeFrame":18},{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":30,"timePerspective":30,"maskingInfo":63},"RANDOMIZED","PARALLEL","randomized, open label","TREATMENT",{"masking":64,"maskingDescription":30,"whoMasked":30},"NONE",[66,69,74],{"label":67,"type":68,"description":30,"interventionNames":30},"No Medication x 3 months, then 25 mg Empagliflozin x 3 months","NO_INTERVENTION",{"label":70,"type":71,"description":30,"interventionNames":72},"Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months","ACTIVE_COMPARATOR",[73],"Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]",{"label":75,"type":71,"description":30,"interventionNames":76},"Empagliflozin 25 mg x 6 months",[77],"Drug: Empagliflozin 25 MG Oral Tablet",[79,84],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":30},"DRUG","Empagliflozin 25 MG Oral Tablet","Empagliflozin, which is sold under the name of Jardiance, is FDA approved for patients 10 years of age and older to improve glycemic control in type 2 diabetes.",[75],{"type":80,"name":85,"description":82,"armGroupLabels":86,"otherNames":30},"Empagliflozin 10 MG Oral Tablet [Jardiance]",[70],[88],{"name":89,"affiliation":5,"role":90},"Melena Bellin, MD","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":30,"email":96},"Peggy Ptacek","CONTACT","612-626-5905","vorwa001@umn.edu",[98],{"facility":5,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-93.26384,44.97997,{"lat":109,"lon":108},[112],{"name":93,"role":94,"phone":30,"phoneExt":30,"email":96},{"type":114,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100610485","phase-4-sglt2i-therapy-in-islet-transplantation-sit-100610485",false,"NCT07228195","SGLT2i Therapy in Islet Transplantation (SIT)","Inclusion Criteria:\n\n* Age 18-70 years old;\n* \\>1 year after TPIAT date at enrollment;\n* Partial islet function defined as stimulated C-peptide ≥0.6 ng\u002FmL at screening\u002Fbaseline visit, AND either (1) on insulin at ≤0.25 unit\u002Fkg\u002Fday OR (2) not on insulin but HbA1c \\>6.5%;\n* Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and \\\u003C25% change in insulin dosing over prior 8 weeks.\n* Willing to manage diabetes medication management\u002Fdose adjustments for the duration of the study with study team MD\n* Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes)\n* Willing to record insulin doses for 14 day intervals x 3 study visits.\n* Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart\n* No prescribed medications other than insulin to treat diabetes in the past 4 weeks.\n\nExclusion Criteria:\n\n* HbA1c \\>9%; on any non-insulin antihyperglycemic medication;\n* History of diabetic ketoacidosis (DKA) in the past 1 year;\n* Unable to drink Boost HP due to true milk protein allergy;\n* Underweight (BMI \\\u003C18.5 kg\u002Fm2) \\[contraindicated by possible weight loss with SGLT2 inhibitors\\];\n* Renal failure defined by glomerular filtration rate \\\u003C30 mL\u002Fmin\u002Fm2;\n* Recurrent dehydration necessitating ED\u002Fhospital visits; one time\u002F rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condition will be exclusionary.\n* Expected to need systemic corticosteroids at \\>25 mg\u002Fday hydrocortisone equivalent over the 6-month study interval;\n* Known allergy to empagliflozin;\n* Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;\n* Unwillingness to consent or return for study visits;\n* Non-English speaking.\n* Any other medical contraindication to treatment or study participation in the opinion of the investigator that would impact either patient's safety or their ability to complete the study.","ALL","18 Years","70 Years",{"count":125,"type":126},40,"ESTIMATED","INTERVENTIONAL",[129],"PHASE4","This pilot clinical trial is designed to gather preliminary data on the efficacy and safety of empagliflozin, a diabetes drug in the sodium-glucose cotransporter 2 inhibitor (SGLT2i) class, in islet autotransplant recipients who have partial islet function.",[132,133,134],"Partial Islet Function","TPIAT","Diabetes","2026-07-21",{"date":137,"type":138},"2026-07-22","ACTUAL",{"date":135,"type":138},{"date":141,"type":126},"2028-12-01",{"name":5,"class":6},1]