SGLT2i Therapy in Islet Transplantation (SIT)

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
randomized, open label
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Peggy Ptacek
vorwa001@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Peggy Ptacek
612-626-5905
vorwa001@umn.edu