Incretin Effect and Use After Clinical Islet Transplantation | RxWiki

Incretin Effect and Use After Clinical Islet Transplantation

Overview[ - collapse ][ - ]

Purpose	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	Type 1 Diabetes
Intervention	Drug: Pantoprazole Drug: Sitagliptin
Phase	Phase 2
Sponsor	University of Alberta
Responsible Party	University of Alberta
ClinicalTrials.gov Identifier	NCT00768651
First Received	October 7, 2008
Last Updated	October 20, 2011
Last verified	October 2011

Tracking Information[ + expand ][ + ]

First Received Date	October 7, 2008
Last Updated Date	October 20, 2011
Start Date	October 2008
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	The primary endpoint will be insulin independence after 6 months of therapy. [Time Frame: 6 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	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] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Incretin Effect and Use After Clinical Islet Transplantation
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
Brief 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.
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 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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 1 Diabetes
Intervention	Drug: Pantoprazole Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months. Other Names: PantolocDrug: Sitagliptin Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months. Other Names: Januvia
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	8
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00768651
Other Study ID Numbers	7331
Has Data Monitoring Committee	No
Information Provided By	University of Alberta
Study Sponsor	University of Alberta
Collaborators	Not Provided
Investigators	Principal Investigator: Peter Senior, MD, PhD University of Alberta
Verification Date	October 2011

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