Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01186562
• Other study ID #: 1006M83756
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 4, 2010
• Last updated: February 29, 2016
• Start date: August 2010
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Pancreatitis

Intervention

Drug:
• Sitagliptin
100 mg PO daily
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin independence		12 months	No
Secondary	Insulin secretion	As measured by mixed meal tolerance test and IV glucose tolerance test	12 and 18 months	No
Secondary	Partial Graft Function	<0.25 u/kg/day with HbA1c <6.5%	12 months and 18 months	No