Table 2.
Active/planned studies related to post-transplant diabetes mellitus in renal transplant recipients, as registered on clinicaltrials.gov
| Identifier | Study title | Design | Description | Expected completion |
|---|---|---|---|---|
| NCT03642184 | Efficacy and Safety of Empagliflozin in NODAT | Open-label RCT | Investigation of the safety and clinical effects of empagliflozin compared with linagliptin in RTR. Outcomes include renal parameters and glycaemic control | December 2020 |
| NCT02083991 | Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation (SAILOR) | Open-label RCT | Evaluation of the effects of a steroid-free, low-dose CNI immunosuppression regimen on the incidence of PTDM in RTR | January 2017 |
| NCT03113110 | Empagliflozin in Post-Transplantation Diabetes Mellitus (EMPTRA-DM) | Phase 2 non-inferiority study | Conversion of RTR with PTDM from insulin (< 40 units per day) to empaglifozin. Outcomes include glycaemic control, weight and blood pressure | December 2019 |
| NCT01928199 | Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant | Phase 2, double-blind RCT | Evaluation of the efficacy of sitagliptin compared with placebo at reducing the incidence of PTDM in RTR who develop hyperglycaemia within 72 h of transplantation | December 2019 |
| NCT02558452 | European Transplant Registry of Senior Renal Transplant Recipients on Advagraf (SENIOR) | Observational (patient registry) | Establishment of a registry of RTR > 65 years old initially treated with once-daily tacrolimus, mycophenolate and steroids. Long-term (10 year) outcomes include graft loss, death, cardiovascular events and development of PTDM | January 2028 |
| NCT02849899 | Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period (PRODIG) | Triple-blind RCT | Comparison of the efficacy vildagliptin versus placebo in reducing the incidence of PTM 1 year post-transplantation | January 2020 |
As of September 2018
Search terms; “post-transplant diabetes mellitus”, “NODAT”. Studies focused on non-renal transplantation were excluded
NODAT new-onset diabetes after transplantation, RCT randomized controlled trial, RTR renal transplant recipients, CNI calcineurin-inhibitor, PTDM post-transplant diabetes mellitus