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Sponsored by: |
University of Alberta |
---|---|
Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00768651 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes |
Drug: Metformin hydrochloride Drug: Pantoprazole Drug: Sitagliptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 8 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are required to meet the following inclusion criteria prior to enrollment:
Subjects must have evidence of early graft dysfunction as defined by:
Exclusion Criteria:
Contact: Peter Senior, MD, PhD | 780-407-8852 | petersenior@ualberta.ca |
Canada, Alberta | |
University of Alberta - Clinical Islet Transplant Program | Recruiting |
Edmonton, Alberta, Canada, T6G2C8 | |
Contact: Janet Wright 780 407 8348 janet.wright@ualberta.ca | |
Principal Investigator: Peter Senior, MD, PhD |
Principal Investigator: | Peter Senior, MD, PhD | University of Alberta |
Responsible Party: | University of Alberta ( Peter Senior, MD, PhD ) |
Study ID Numbers: | 7331 |
Study First Received: | October 7, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00768651 |
Health Authority: | Canada: Health Canada |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Pantoprazole Metformin Benzocaine |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Anti-Ulcer Agents |
Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |