Recruiting

Empagliflozin

Sponsor:

University of Minnesota

Code:

NCT07228195

Conditions

Partial Islet Function

TPIAT

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 MG Oral Tablet

Empagliflozin 10 MG Oral Tablet [Jardiance]

Study Details

Brief 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.

Conditions

Partial Islet Function

TPIAT

Diabetes

Study ID

NCT07228195

Start date

Jul 21, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No Medication x 3 months, then 25 mg Empagliflozin x 3 months

active comparator: Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months

active comparator: Empagliflozin 25 mg x 6 months

Interventions

Empagliflozin 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.

Empagliflozin 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.

Primary outcome measure

  • Time In Range (TIR) 70- 180 mg/dL [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Peggy Ptacek

612-626-5905vorwa001@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Peggy Ptacek

vorwa001@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-22.