SGLT2i Therapy in Islet Transplantation (SIT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Partial Islet Function; TPIAT
• Intervention / Treatment: Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]; Drug: Empagliflozin 25 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Peggy Ptacek; Phone Number: 612-626-5905; Email: vorwa001@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
      • Contact: Peggy Ptacek; Email: vorwa001@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 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.
Active Comparator: Empagliflozin 25 mg x 6 months	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Tight Range (TITR) 70-140 mg/dL	from 14 days of home monitoring	Month 3
Time in Tight Range (TITR) 70-140 mg/dL	from 14 days of home monitoring	Month 6
Time in hypoglycemia <70 mg/dL	from 14 days of home monitoring	Month 3
Time in hypoglycemia <70 mg/dL	from 14 days of home monitoring	Month 6
Time in hypoglycemia <54 mg/dL	from 14 days of home monitoring	Month 3
Time in hypoglycemia <54 mg/dL	from 14 days of home monitoring	Month 6
Time in hyperglycemia >180 mg/dL	from 14 days of home monitoring	Month 3
Time in hyperglycemia >180 mg/dL	from 14 days of home monitoring	Month 6
Area under the curve 2 hour glucose from MMTT		Month 3
Area under the curve 2 hour glucose from MMTT		Month 6
Hemoglobin A1c level		Month 3
Hemoglobin A1c level		Month 6
Proinsulin	C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)	Month 3
Proinsulin	C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)	Month 6
Proportion of patients with ketones >=1.5	Routine home serum ketone testing	Month 3
Proportion of patients with ketones >=1.5	Routine home serum ketone testing	Month 6
ED/ hospital visits for diabetic ketoacidosis (DKA)	number of visits	Month 3
ED/ hospital visits for diabetic ketoacidosis (DKA)	number of visits	Month 6
Occurrence of urinary or genital tract infection		Month 3
Occurrence of urinary or genital tract infection		Month 6
Weight change	% weight loss or weight gain	Month 3
Weight change	% weight loss or weight gain	Month 6
Diabetes distress	Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."	Month 3
Diabetes distress	Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."	Month 6

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Melena Bellin, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: November 12, 2025
• First Posted (Actual): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Pharmaceutical Preparations; Dosage Forms; empagliflozin; Tablets
• Other Study ID Numbers: PEDS-2025-34226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No