Trial registrationĪustralian New Zealand Clinical Trials Registry ACTRN12614001171606.
Larger randomised controlled trials (RCTs) are needed to establish and confirm the efficacy and safety of metformin post renal transplantation. The use of metformin post renal transplantation appeared feasible and safe. There was no difference in secondary outcomes relating to the metabolic profile. Tolerability and efficacy was similar between the 2 groups with no serious adverse events. Ten patients were randomised to metformin and 9 patients to standard care. Seventy eight patients had an OGTT over 24 months, 25 of them had IGT, of those, 19 patients were randomised, giving a feasibility of recruitment of 24.4%. Participants had an oral glucose tolerance test (OGTT) in the 4–12 weeks post-transplantation those with IGT were randomised to standard care or standard care and metformin 500 mg twice daily and followed up for 12 months. Transplantation and Diabetes (Transdiab) is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Metformin has proven benefits in the general population and might be advantageous in the prevention and management of PTDM. Post transplantation diabetes mellitus (PTDM) is a common and serious complication after renal transplantation with significant morbidity and mortality.
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