Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation-a randomized, double-blind, placebo-controlled trial.
Haidinger M, Werzowa J, et al.American Journal of Transplantation 2014;14(1):115-23
Aims
To examine the effects of vildagliptin and lifestyle instructions in stable kidney transplant recipients with newly diagnosed new onset of diabetes after transplantation (NODAT) compared to lifestyle instructions alone.
Interventions
All patients were given instructions regarding diet and physical activity and administered with either 50mg vildagliptin or placebo tablets once daily.
Participants
33 new onset of diabetes after kidney transplantation.
Outcomes
The primary outcome of the study was the difference in the intra-individual change in oral glucose tolerance test-derived (OGTT) 2 hour plasma glucose (2HPG). The secondary outcomes included the differences between two study groups in the intra-individual change in OGTT-derived 2HPG from baseline to 4 months, fasting plasma glucose, HbA1c and fasting insulin within the groups before and after treatment, rate of side-effects, change in glomerular filtration rate, albuminuria/proteinuria, change in liver function parameters from baseline, and immunosuppressant serum levels.
Follow-up
16 weeks
CET Conclusions
Vildaglibetin is an inhibitor of dipeptidyl peptidase-4 and selectively increases insulin secretion without inducing hypoglycaemia. Patients selected from this one centre’s follow-up clinic with stable renal function resulted in 63 with a raised two hour oral glucose tolerance test. 33 were randomised to receive vildaglibetin and 30 a placebo. Immunosuppression comprised CNIs, mycophenolate and steroids. There was a significant reduction in two hourly oral glucose tolerance results and also a reduction in HBA1c. The numbers of course were small but there was little in the way of safety problems and vildaglibetin did appear efficient in achieving glycemic control with short term treatment.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT00980356