Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

At the current time, about one-third of patients are insulin independent (do not need to
take insulin) after autotransplant, but the other two-thirds still need some insulin.
Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or
GLP-1, in the body which then increases the amount of insulin that is made by the beta
cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells
from dying under stressful conditions and increase the production of new beta cells.

The primary goal of this study is to see if taking sitagliptin for one year after islet
autotransplant increases the number of patients who achieve and maintain insulin
independence. Other goals of this study are to see if sitagliptin reduces the amount of
insulin injections needed or helps the islets make more insulin.

Inclusion Criteria:

- Age ≥18 years

- Scheduled for total pancreatectomy and IAT at UM

Exclusion Criteria:

- Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl

- Medical conditions which, in the opinion of the investigator, might impact islet
function (e.g asthma or inflammatory disease requiring chronic systemic
corticosteroids)

- Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5
mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal
dialysis.

- For female subjects, plans to become pregnant or unwillingness to practice birth
control for 18 months.

- Islet yield <1,000 IE/kg body weight (exclusion for treatment with drug/placebo)