Efficacy and safety of imeglimin add‐on to DPP‐4 inhibitor therapy in Japanese patients with type 2 diabetes mellitus: An interim analysis of the randomised, double‐blind FAMILIAR trial

Abstract Aims The ongoing FAMILIAR trial aims to provide evidence for clinical decision‐making and offer a novel treatment paradigm in type 2 diabetes mellitus (T2DM) management. The interim findings of FAMILIAR through Week 24 are reported. Materials and Methods FAMILIAR is a multicentre, randomised, double‐blind study comparing the efficacy and safety of imeglimin versus placebo in adult Japanese patients with T2DM and inadequate glycaemic control despite dipeptidyl peptidase‐4 (DPP‐4) inhibitor monotherapy, plus diet/exercise modifications. Patients entered a 24‐week double‐blind treatment phase (oral imeglimin 1000 mg or placebo twice daily) followed by an 80‐week open‐label phase (oral imeglimin 1000 mg twice daily). The primary end‐point was change in glycated haemoglobin (HbA1c) level from baseline at Week 24. Safety was also monitored. Results Overall, 117 patients were randomised (imeglimin, n = 58; placebo, n = 54; excluded, n = 5). The least squares mean (standard error) changes in HbA1c level (baseline to Week 24) for the imeglimin and placebo groups, respectively, were −0.65% (0.11%) and 0.38% (0.11%) in the overall population (group‐difference −1.02% [95% confidence interval −1.33%, −0.72%]; p < 0.001); −0.47% (0.17%) and 0.32% (0.18%) in patients aged <65 years (−0.79% [−1.29%, −0.29%]; p = 0.003); and −0.80% (0.14%) and 0.42% (0.14%) in patients aged ≥65 years (−1.22% [−1.61%, −0.82%]; p < 0.001). One patient in the imeglimin group had mild hypoglycaemia; the safety profile was favourable. Conclusions Imeglimin represents a potential new treatment option for patients with T2DM and inadequate glycaemic control with DPP‐4 inhibitors, including those aged ≥65 years. Clinical Trial Registration jRCTs061210082.