Diabetes, Partial Islet Function, TPIAT
Conditions
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.
Interventions
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, 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time in Tight Range (TITR) 70-140 mg/dL | Month 3 | from 14 days of home monitoring |
| Time in hypoglycemia <70 mg/dL | Month 3 | from 14 days of home monitoring |
| Time in hypoglycemia <54 mg/dL | Month 3 | from 14 days of home monitoring |
| Time in hyperglycemia >180 mg/dL | Month 3 | from 14 days of home monitoring |
| Area under the curve 2 hour glucose from MMTT | Month 3 | — |
| Hemoglobin A1c level | Month 3 | — |
| Proinsulin | Month 3 | C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker) |
| Proportion of patients with ketones >=1.5 | Month 3 | Routine home serum ketone testing |
| ED/ hospital visits for diabetic ketoacidosis (DKA) | Month 3 | number of visits |
| Occurrence of urinary or genital tract infection | Month 3 | — |
| Weight change | Month 3 | % weight loss or weight gain |
| Diabetes distress | Month 3 | Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." |
Countries
United States
Contacts
CONTACTPeggy Ptacek
PRINCIPAL_INVESTIGATORMelena Bellin, MD
University of Minnesota
Outcome results
None listed