Incretin Effect and Use After Clinical Islet Transplantation
Information source: University of Alberta
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Metformin hydrochloride (Drug); Pantoprazole (Drug); Sitagliptin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Alberta Official(s) and/or principal investigator(s):
Peter Senior, MD, PhD, Principal Investigator, Affiliation: University of Alberta
Overall contact:
Peter Senior, MD, PhD, Phone: 780-407-8852, Email: petersenior@ualberta.ca
Summary
We aim to study if the administration of medications to increase the secretion of hormones
from the intestines can improve glycemic control, reduce insulin use and promote β-cell
regeneration/expansion in subjects with type 1 diabetes following islet transplantation who
are back using small doses of insulin because of early graft dysfunction. We believe that
the results will enable us to understand whether these drugs could be useful in islet
transplant recipients, particularly if glycemic control deteriorates.
Clinical Details
Official title: Pilot Study of Safety and Efficacy of Combined Use of Dipeptidyl-peptidase Inhibitor (Sitagliptin), Proton Pump Inhibitor (Pantoprazole) and Metformin to Prevent Beta-cell Apoptosis and Promote Islet Regeneration in Islet Transplant Recipients With Early Graft Dysfunction
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: The primary endpoint will be insulin independence after 6 months of therapy.
Secondary outcome: Insulin independence after the 3 month washout period; insulin and C-peptide responses to the intravenous arginine and mixed meal tests; reduction in insulin use; and improvement in glycemic control as determined by HbA1c and CGMS.
Detailed description:
This is a single centre non-randomized pilot study. Subjects will be recruited from the
current cohort of islet transplant recipients at the University of Alberta.
The objective is to study whether the combination of sitagliptin, pantoprazole and metformin
can restore insulin independence in previously insulin independent islet transplant
recipients experiencing early graft dysfunction.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Subjects are required to meet the following inclusion criteria prior to enrollment:
1. Subjects must have evidence of early graft dysfunction as defined by:
1. Insulin independence with sub-optimal glycemic control as indicated by HbA1c >6%
or fasting glucose > 7 mmol/L or random glucose > 10 mmol/L; or
2. Total insulin use of ≤ 10 units/day.
2. Subjects must have detectable C-peptide.
3. Subject must be capable of understanding the purpose and risks of the study and must
sign a statement of informed consent
Exclusion Criteria:
1. Insulin independence with sub-optimal glycemic control as indicated by HbA1c <6% or
fasting glucose <7 mmol/L or random glucose <10 mmol/L; or
2. Total insulin use of ≥10 units/day.
3. Subjects must not have detectable C-peptide.
Locations and Contacts
Peter Senior, MD, PhD, Phone: 780-407-8852, Email: petersenior@ualberta.ca
University of Alberta - Clinical Islet Transplant Program, Edmonton, Alberta T6G2C8, Canada; Recruiting
Janet Wright, Phone: 780 407 8348, Email: janet.wright@ualberta.ca
Peter Senior, MD, PhD, Principal Investigator
Additional Information
Starting date: October 2008
Ending date: September 2011
Last updated: October 1, 2009
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