drugset / Trial / NCT01268995

Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation

NCT01268995

Phase 2 Terminated 32 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelTreatment

Summary

New onset diabetes after transplantation (NODAT) is a frequent and feared complication after kidney transplantation and leads to an increase in cardiovascular complications as well as in the rate of graft loss. Very little data exist on how patients in which NODAT has been diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the function of the insulin secreting cells in the pancreas. Therefore, the investigators test the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed NODAT who have just started early treatment with insulin. The hypothesis is that patients who are treated with insulin and who are switched to Cyclosporine A have improved glucose metabolism compared to patients who are treated with insulin and who remain on Tacrolimus therapy.

Timeline

Start
2009-09
Primary completion
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 3 mg/kg
Comparator Tacrolimus Small molecule