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Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

This study has been completed.
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: January 30, 2017
Last verified: January 2017
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Insulin Independence [ Time Frame: 12 months ]
    percentage of patients insulin independent


Secondary Outcome Measures:
  • Insulin Independence [ Time Frame: 18 months ]
    percentage of patients insulin independent

  • 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)

  • 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)

  • 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)

  • 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)


Enrollment: 83
Study Start Date: August 2010
Study Completion Date: June 2016
Primary Completion Date: July 2015 (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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186562

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
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

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
Results First Received: October 28, 2016
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
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

ClinicalTrials.gov processed this record on May 25, 2017