Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

NCT ID: NCT01186562

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

Pancreatitis; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sitagliptin

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

100 mg PO daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Sitagliptin

100 mg PO daily

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melena Bellin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Harindhanavudhi T, Yang Y, Hodges JS, Pruett TL, Kirchner V, Beilman GJ, Bellin MD. Body Composition is Associated With Islet Function After Pancreatectomy and Islet Autotransplantation for Pancreatitis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e496-e506. doi: 10.1210/clinem/dgaa790.

Reference Type: DERIVED

PMID: 33124670 (View on PubMed)

Other Identifiers

1006M83756

Identifier Type: -

Identifier Source: org_study_id