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Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

This study is currently recruiting participants.
Verified March 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01186562
First received: August 4, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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. 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.


Condition Intervention Phase
Pancreatitis
Diabetes
 Drug: Sitagliptin
Drug: Placebo
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Insulin independence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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%


Estimated Enrollment: 90
Study Start Date: August 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin Drug: Sitagliptin
100 mg PO daily
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186562

Contacts
Contact: Melena D. Bellin, M.D. 612 625-4686 bell0130@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Melena D. Bellin, M.D.     612-625-4686     bell0130@umn.edu    
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Melena Bellin, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01186562     History of Changes
Other Study ID Numbers: 1006M83756
Study First Received: August 4, 2010
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Pancreatitis
Pancreatectomy
Islet autotransplant
Sitagliptin
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Pancreatitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pancreatic Diseases
Digestive System Diseases
Sitagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013