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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGTime 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
Time frame: Month 3
Time in Tight Range (TITR) 70-140 mg/dL
from 14 days of home monitoring
Time frame: Month 3
Time in Tight Range (TITR) 70-140 mg/dL
from 14 days of home monitoring
Time frame: Month 6
Time in hypoglycemia <70 mg/dL
from 14 days of home monitoring
Time frame: Month 3
Time in hypoglycemia <70 mg/dL
from 14 days of home monitoring
Time frame: Month 6
Time in hypoglycemia <54 mg/dL
from 14 days of home monitoring
Time frame: Month 3
Time in hypoglycemia <54 mg/dL
from 14 days of home monitoring
Time frame: Month 6
Time in hyperglycemia >180 mg/dL
from 14 days of home monitoring
Time frame: Month 3
Time in hyperglycemia >180 mg/dL
from 14 days of home monitoring
Time frame: Month 6
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Area under the curve 2 hour glucose from MMTT
Time frame: Month 3
Area under the curve 2 hour glucose from MMTT
Time frame: Month 6
Hemoglobin A1c level
Time frame: Month 3
Hemoglobin A1c level
Time frame: Month 6
Proinsulin
C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)
Time frame: Month 3
Proinsulin
C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)
Time frame: Month 6
Proportion of patients with ketones >=1.5
Routine home serum ketone testing
Time frame: Month 3
Proportion of patients with ketones >=1.5
Routine home serum ketone testing
Time frame: Month 6
ED/ hospital visits for diabetic ketoacidosis (DKA)
number of visits
Time frame: Month 3
ED/ hospital visits for diabetic ketoacidosis (DKA)
number of visits
Time frame: Month 6
Occurrence of urinary or genital tract infection
Time frame: Month 3
Occurrence of urinary or genital tract infection
Time frame: Month 6
Weight change
% weight loss or weight gain
Time frame: Month 3
Weight change
% weight loss or weight gain
Time frame: 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."
Time frame: 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."
Time frame: Month 6