SGLT2i Therapy After Islet Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 pilot trial evaluates the safety and potential benefits of empagliflozin in adults who underwent islet autotransplantation for diabetes and still have partial islet activity. Participants take empagliflozin in standard tablet forms (25 mg or 10 mg) and monitor glucose while continuing their usual diabetes regimen. The study requires sustained diabetes management, CGM use, and regular clinic visits over about three months between visits at the University of Minnesota. Eligible participants must have partial islet function, be off or on low-dose insulin with reasonable glycemic control, and be willing to adhere to study procedures. Exclusion criteria include an HbA1c above 9% or use of non-insulin antihyperglycemics prior to enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Melena Bellin, MD — University of Minnesota
• Study coordinator: Peggy Ptacek
• Email: vorwa001@umn.edu
• Phone: 612-626-5905

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.