Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Phase 4

Completed

• Conditions: Pancreatitis; Diabetes
• Interventions: Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT01186562
• Lead Sponsor: University of Minnesota

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 chronic pancreatitis.

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 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2015-07
• Study Completion: 2016-06
• Results First Submitted: 2016-10-28
• Results First Submitted QC: 2016-10-28
• Results First Posted: 2016-12-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Sitagliptin	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Insulin Independence	12 months	percentage of patients insulin independent

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) C-peptide (ng/dL*Min)	12 months	AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)
AUC C-peptide	18 months	AUC C-peptide (ng/dL\*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)
Insulin Independence	18 months	percentage of patients insulin independent
Acute C-peptide Response (ACR) to Glucose	18 months	Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States