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.