Health Trials

SGLT2i Therapy in Islet Transplantation (SIT)

ConditionsPartial Islet FunctionTPIATDiabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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];

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 25 MG Oral Tablet

    Drug

    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 10 MG Oral Tablet [Jardiance]

    Drug

    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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: No Medication x 3 months, then 25 mg Empagliflozin x 3 monthsNo intervention 0 interventions
Group B: Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 monthsActive comparator 1 intervention
Group C: Empagliflozin 25 mg x 6 monthsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Month 3

Secondary outcomes

1

Time in Tight Range (TITR) 70-140 mg/dL

from 14 days of home monitoring

Time frame
Month 3
2

Time in Tight Range (TITR) 70-140 mg/dL

from 14 days of home monitoring

Time frame
Month 6
3

Time in hypoglycemia <70 mg/dL

from 14 days of home monitoring

Time frame
Month 3
4

Time in hypoglycemia <70 mg/dL

from 14 days of home monitoring

Time frame
Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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