Status:
COMPLETED
Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
Lead Sponsor:
University of Minnesota
Conditions:
Pancreatitis
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 chro...
Detailed 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 incr...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Scheduled for total pancreatectomy and IAT at UM
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01186562
Start Date
August 1 2010
End Date
June 1 2016
Last Update
May 31 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455