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