Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Placebo Controlled Intervention Study to Assess the Impact of Sitagliptin 100 mg/Day for 1 Year on Insulin Independence Following Pancreatectomy and Autoislet Transplantation|
- Insulin independence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Insulin secretion [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]As measured by mixed meal tolerance test and IV glucose tolerance test
- Partial Graft Function [ Time Frame: 12 months and 18 months ] [ Designated as safety issue: No ]<0.25 u/kg/day with HbA1c <6.5%
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Sitagliptin||
100 mg PO daily
|Placebo Comparator: Placebo||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186562
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Melena Bellin, MD||University of Minnesota - Clinical and Translational Science Institute|