SGLT2i Therapy in Islet Transplantation (SIT)
University of 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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 \<25% change in insulin dosing over prior 8 weeks. * Willing to manage diabetes medication management/dose adjustments for the duration of the study with study team MD * Willing to wear continuous glucose monitor f…
Interventions
- DrugEmpagliflozin 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.
- DrugEmpagliflozin 10 MG Oral Tablet [Jardiance]
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.
Location
- University of MinnesotaMinneapolis, Minnesota