SGLT2i Therapy in Islet Transplantation (SIT)

Not Applicable

Not yet recruiting

• Conditions: Partial Islet Function; TPIAT; Diabetes
• Interventions: Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]; Drug: Empagliflozin 25 MG Oral Tablet

• Registration Number: NCT07228195
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-17
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-12
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Study Start: 2025-12-01
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months	Empagliflozin 10 MG Oral Tablet [Jardiance]	-
Empagliflozin 25 mg x 6 months	Empagliflozin 25 MG Oral Tablet	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States