Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

University of Minnesota83 enrolled

Overview

The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pancreatitis Diabetes

Interventions

SitagliptinDRUG

100 mg PO daily

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Insulin Independence

percentage of patients insulin independent

Time frame: 12 months

Secondary Outcomes

Insulin Independence

percentage of patients insulin independent

Time frame: 18 months

Area Under the Curve (AUC) C-peptide (ng/dL*Min)

AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)

Time frame: 12 months

AUC C-peptide

AUC C-peptide (ng/dL\*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)

Time frame: 18 months

Acute C-peptide Response (ACR) to Glucose

Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)

Time frame: 12 months

Acute C-peptide Response (ACR) to Glucose

Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)

Time frame: 18 months

Data from ClinicalTrials.gov

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