drugset / Trial / NCT01092806

Insulin Secretion and Advagraf

NCT01092806 ↗

Non-randomizedCrossoverOpen-labelPrevention

Summary

One of the main side-effects of tacrolimus in solid organ transplanted patients is post transplant diabetes mellitus (PTDM). It is not known if different pharmacokinetic properties influence the risk of developing PTDM. It is possible that it either is high peak concentrations of high overall systemic exponation that is responsible for the effect on insulin secretion. With the new slow-release formulation of tacrolimus (Advagraf) a different pharmacokinetic profile is introduced to patients and it is of interest to investigate if this affects insulin secretion and insulin sensitivity of patients. Hypothesis: The pharmacokinetic profile of tacrolimus affects the insulin secretion in renal transplant recipients.

Timeline

Start
2009-10
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule — —