Incretin Effect and Use After Clinical Islet Transplantation
This trial is active, not recruiting.
|Condition||type 1 diabetes|
|Sponsor||University of Alberta|
|Start date||October 2008|
|End date||December 2011|
|Trial size||8 participants|
|Trial identifier||NCT00768651, 7331|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
The primary endpoint will be insulin independence after 6 months of therapy.
time frame: 6 months
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.
time frame: 3 months
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria Subjects must meet the following criteria to be enrolled in this study: 1. Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta. 2. Insulin independent for 3 months or longer after islet transplant. 3. Early graft dysfunction as defined by: 1. HbA1c >6% (but less than 7.5%); or 2. fasting glucose > 7 mmol/L (126 mg/dl); or 3. random glucose > 10 mmol/L (180 mg/dl), and 4. Total insulin use of < 10 units/day. 4. C-peptide positive. 5. Able to provide informed consent. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Unable to provide informed consent. 2. Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months. 3. Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators). 4. Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs: 1. Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation. 2. Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by GFR <50 ml/min/1.73m2). 3. Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis). 5. Uncontrolled hyperglycemia 6. Any subject that in the opinion of the investigator would not be a good candidate for study participation.
|Official title||Pilot Study of Safety and Efficacy of Combined Use of Dipeptidyl-peptidase Inhibitor (Sitagliptin) and Proton Pump Inhibitor (Pantoprazole) to Prevent Beta-cell Apoptosis and Promote Islet Regeneration in Islet Transplant Recipients With Early Graft Dysfunction|
|Principal investigator||Peter Senior, MD, PhD|
|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 primary objective off the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. The study will also evaluate the safety of the combination drug therapy.|
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