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Effect of Sitagliptin on Graft Function Following Islet Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00853944
First received: February 26, 2009
Last updated: February 15, 2011
Last verified: February 2011
History of Changes
  Purpose

Islet transplantation requires a large number of islets required to achieve insulin independence and the function of the transplanted islets progressively declines over time. Evidence from animal studies and human islets in culture suggests that increasing GLP-1 levels could help with both of these problems. This study is designed to test this hypothesis using sitagliptin in a randomized clinical trial.


Condition Intervention Phase
Islet Transplantation
 Drug: sitagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Determine if Sitagliptin Will Enhance Islet Graft Function When Given for 1 Year Following Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Islet function as measured by hyperglycemic clamp [ Time Frame: 3 and 12 months ± 2 weeks after islet infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in insulin requirement (absolute and % decrease from pre-transplant dose) [ Time Frame: 1 week prior to stopping the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Arms Assigned Interventions
No Intervention: P
subjects take 1 tablet of placebo daily
Experimental: S
subjects take 1 tablet of sitagliptin 100 mg daily
 Drug: sitagliptin
Subjects receive sitagliptin 100 mg po daily from the day of islet transplant until completion of the study
Other Names:
  • Januvia
  • DPP-IV inhibitor
  • GLP-1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes for > 5 years with negative C peptide, GFR > 70 ml/min, BMI ≤ 28 and non-smoker for ≥ 1 year

Exclusion Criteria:

  • Known hypersensitivity to sitagliptin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853944

Contacts
Contact: Sharon Kozak 604-875-5997 sekozak@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Sharon Kozak     604-875-5997     sekozak@vch.ca    
Sponsors and Collaborators
University of British Columbia
Merck
Investigators
Principal Investigator: David M. Thompson, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. David M. Thompson, University of British Columbia
ClinicalTrials.gov Identifier: NCT00853944     History of Changes
Other Study ID Numbers: H08-01947
Study First Received: February 26, 2009
Last Updated: February 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
islet transplantation
type 1 diabetes
incretin

Additional relevant MeSH terms:
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 23, 2013