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Recruiting
NCT07228195
SGLT2i Therapy in Islet Transplantation (SIT)
Conditions: Partial Islet Function, TPIAT, Diabetes
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: University of Minnesota
Location: University of Minnesota Minneapolis Minnesota
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18-70 years old;
* \>1 year after TPIAT date at enrollment;
* Partial islet function defined as stimulated C-peptide ≥0.6 ng/mL at screening/baseline visit, AND either (1) on insulin at ≤0.25 unit/kg/day OR (2) not on insulin but HbA1c \>6.5%;
* Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and \9%; on any non-insulin antihyperglycemic medication;
* History of diabetic ketoacidosis (DKA) in the past 1 year;
* Unable to drink Boost HP due to true milk protein allergy;
* Underweight (BMI \
Source: ClinicalTrials.gov (NCT07228195). StuddyBuddy aggregates publicly available trial information.
