SGLT2i Therapy in Islet Transplantation (SIT) Study

This study is looking at empagliflozin (Jardiance), a diabetes medicine, in people who have had an islet autotransplant and still have some islet function. The goal is to see how well empagliflozin works and if it's safe for you. You might be able to join if you are 18 to 70 years old, had your islet transplant over a year ago, and have partial islet function (meaning your body still makes some C-peptide, a substance related to insulin). The study will measure your "Time In Range" (TIR), which is how long your blood sugar stays within a healthy range, after three months. The current status of this study is unclear, and it plans to enroll 40 participants.

Study design: This is a pilot interventional study, meaning it's an early study to gather preliminary information. It plans to enroll 40 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, Time In Range, is measured at Month 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

SGLT2i Therapy in Islet Transplantation (SIT)

Recruiting

PHASE4Ages 18–70InterventionalTreatment

University of Minnesota

~40 participants

Updated 2026-07-22 on ClinicalTrials.gov

What's tested:Empagliflozin 25 MG Oral TabletEmpagliflozin 10 MG Oral Tablet [Jardiance]

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Time In Range (TIR) 70- 180 mg/dL

Measured over Month 3

Conditions

Partial Islet Function

TPIAT

Diabetes

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Melena Bellin, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Peggy Ptacek

[email protected]

612-626-5905

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Time In Range (TIR) 70- 180 mg/dLMonth 3
the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment

Trialytics