Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

University of Minnesota (UMN)

Status and phase

Completed

Phase 4

Conditions

Diabetes

Pancreatitis

Treatments

Drug: Sitagliptin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01186562

1006M83756

Details and patient eligibility

About

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.

Full description

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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)