Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo-controlled clinical trial.
Werzowa J, Hecking M, et al.Transplantation 2013; 95(3): 456-462.
Aims
To investigate the treatment of the β-cell protective agent vildagliptin and insulin sensitive pioglitazone for antihyperglycemic control in kidney transplant recipients with impaired glucose tolerance.
Interventions
Three randomized groups received 50 mg Vildagliptin, 30 mg Pioglitazone or placebo once daily, for 3 months.
Participants
48 renal transplant recipients with stable graft function and impaired glucose tolerance.
Outcomes
The primary outcome was the difference in change in 2 –hour plasma glucose (2HPG) between the three groups. The secondary outcomes included the difference in 2HPG, fasting plasma glucose, HbA1c and fasting insulin within the groups before and after treatment, change in kidney function, change in liver parameters and the rate of side effects.
Follow-up
3 months.
CET Conclusions
In this interesting study, patients with stable renal function who were at least 6 months from the time of transplantation with a newly diagnosed impaired glucose tolerance were randomly allocated to vildagliptin, pioglitazone or a placebo for three months. All patients received lifestyle counselling. In both treatment groups there was a reduction in two hour plasma glucose at 3 months and this was also reflected by the HBA1C levels in comparison to the controls. There were only a few mild adverse events and these occurred at a similar rate in all three groups.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov – NCT01346254