Phase 3Completed

Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period (PRODIG)

Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period

Sponsor
Centre Hospitalier Universitaire de Besancon (Academic or other)
Enrolment
47 enrolled
Conditions
Disorder Related to Renal Transplantation; Diabetes
Interventions
Vildagliptin; Placebo
Ages
adults, older adults
Registry
NCT02849899

From the registry

Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation. There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group. No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes.…

Primary outcomes

  • Diabetes event
Full record on ClinicalTrials.gov