Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Completed · Phase 4 · Has a placebo group

Conditions studied: Pancreatitis, Diabetes

In brief

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.

Key facts

Study ID

NCT01186562

Run by

University of Minnesota

People needed

83

Starts

2010-08-01

Expected to finish

2016-06-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Scheduled for total pancreatectomy and IAT at UM

You may not qualify if…

• 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)

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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