CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Pantoprazole +1 moredrug
Likely dose
Pantoprazole 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00768651
NCT00768651Phase 2Completed

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

University of Alberta·interventional·Posted Oct 8, 2008·Updated Jun 18, 2015

In Brief

A Phase 2 clinical trial evaluating Pantoprazole and Sitagliptin for Type 1 Diabetes. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesCanada

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

Pantoprazoledrug

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.

Sitagliptindrug

Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.