Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

• ClinicalTrials.gov Identifier: NCT01186562
• Recruitment Status: Completed
• First Posted: August 23, 2010
• Results First Posted: December 28, 2016
• Last Update Posted: May 31, 2017
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatitis; Diabetes	Drug: Sitagliptin; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: August 2010
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sitagliptin	Drug: Sitagliptin; 100 mg PO daily
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Insulin Independence [ Time Frame: 12 months ]
   percentage of patients insulin independent

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Melena Bellin, MD; University of Minnesota

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01186562
• Other Study ID Numbers: 1006M83756
• First Posted: August 23, 2010
• Results First Posted: December 28, 2016
• Last Update Posted: May 31, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Minnesota:

Pancreatitis; Pancreatectomy; Islet autotransplant; Sitagliptin; Diabetes

Additional relevant MeSH terms:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Sitagliptin Phosphate; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action