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SGLT2i Therapy in Islet Transplantation (SIT) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

SGLT2i Therapy in Islet Transplantation (SIT)

NCT07228195•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

18 - 70 years

Sex

ALL

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;
+2 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

May 15, 2026

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

Partial Islet FunctionTPIATDiabetes

Interventions

Empagliflozin 25 MG Oral Tablet

DRUG

Empagliflozin 10 MG Oral Tablet [Jardiance]

DRUG

Contacts

Peggy Ptacek

CONTACT

612-626-5905 vorwa001@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SGLT2i Therapy in Islet Transplantation (SIT)

Inclusion Criteria

Exclusion Criteria

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