Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Sitagliptin Phosphate

Criteria

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)