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Effect of Sitagliptin on Graft Function Following Islet Transplantation

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ClinicalTrials.gov Identifier: NCT00853944
Recruitment Status : Terminated (Sponsor withdrew funding du to lack of enrollment. Lack of enrollment was due to decrease in number of islet transplant procedures)
First Posted : March 2, 2009
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Thompson, University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Islet Transplantation Drug: sitagliptin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : July 2009
Actual Primary Completion Date : November 1, 2013
Actual Study Completion Date : November 1, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Islet function as measured by hyperglycemic clamp [ Time Frame: 3 and 12 months ± 2 weeks after islet infusion ]

Secondary Outcome Measures :
  1. Change in insulin requirement (absolute and % decrease from pre-transplant dose) [ Time Frame: 1 week prior to stopping the study ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853944


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: David M. Thompson, MD University of British Columbia

Responsible Party: David Thompson, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00853944     History of Changes
Other Study ID Numbers: H08-01947
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
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