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Effect of Sitagliptin on Graft Function Following Islet Transplantation

This study has been terminated.
(Sponsor withdrew funding du to lack of enrollment. Lack of enrollment was due to decrease in number of islet transplant procedures)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853944
First Posted: March 2, 2009
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Thompson, University of British Columbia
  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
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

Resource links provided by NLM:


Further study details as provided by David Thompson, 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 ]

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

Estimated Enrollment: 12
Study Start Date: July 2009
Study Completion Date: November 1, 2013
Primary Completion Date: November 1, 2013 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

Responsible Party: David Thompson, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00853944     History of Changes
Other Study ID Numbers: H08-01947
First Submitted: February 26, 2009
First Posted: March 2, 2009
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