Study Stopped
Sponsor withdrew funding du to lack of enrollment. Lack of enrollment was due to decrease in number of islet transplant procedures
Effect of Sitagliptin on Graft Function Following Islet Transplantation
A Randomized Controlled Trial to Determine if Sitagliptin Will Enhance Islet Graft Function When Given for 1 Year Following Transplantation
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedOctober 30, 2017
October 1, 2017
4.3 years
February 26, 2009
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Islet function as measured by hyperglycemic clamp
3 and 12 months ± 2 weeks after islet infusion
Secondary Outcomes (1)
Change in insulin requirement (absolute and % decrease from pre-transplant dose)
1 week prior to stopping the study
Study Arms (2)
P
NO INTERVENTIONsubjects take 1 tablet of placebo daily
S
EXPERIMENTALsubjects take 1 tablet of sitagliptin 100 mg daily
Interventions
Subjects receive sitagliptin 100 mg po daily from the day of islet transplant until completion of the study
Eligibility Criteria
You may qualify if:
- Type 1 diabetes for \> 5 years with negative C peptide, GFR \> 70 ml/min, BMI ≤ 28 and non-smoker for ≥ 1 year
You may not qualify if:
- Known hypersensitivity to sitagliptin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David M. Thompson, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 2, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
October 30, 2017
Record last verified: 2017-10