SGLT2i Therapy in Islet Transplantation (SIT)

University of Minnesota (UMN)

Status and phase

Begins enrollment this month

Phase 4

Conditions

Diabetes

TPIAT

Partial Islet Function

Treatments

Drug: Empagliflozin 25 MG Oral Tablet

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Study type

Interventional

Funder types

Other

Identifiers

NCT07228195

PEDS-2025-34226

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 for diabetes management (currently standard of care for TPIAT diabetes)
Willing to record insulin doses for 14 day intervals x 3 study visits.
Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart
No prescribed medications other than insulin to treat diabetes in the past 4 weeks.

Exclusion criteria

HbA1c >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 <18.5 kg/m2) [contraindicated by possible weight loss with SGLT2 inhibitors];
Renal failure defined by glomerular filtration rate <30 mL/min/m2;
Recurrent dehydration necessitating ED/hospital visits; one time/ rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condition will be exclusionary.
Expected to need systemic corticosteroids at >25 mg/day hydrocortisone equivalent over the 6-month study interval;
Known allergy to empagliflozin;
Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;
Unwillingness to consent or return for study visits;
Non-English speaking.
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.