Dubourg J, Fouqueray P, Quinslot D, et al. - In Japanese patients with type 2 diabetes, treatment using imeglimin offered well-tolerated long-term safety as well as efficacy in both mono- and oral combination therapy.

• In a phase 3 pivotal open-label trial (TIMES 2), a total of 714 patients with type 2 diabetes inadequately controlled despite diet/exercise or despite treatment with a single agent from one of several available classes of antidiabetic drugs along with diet/exercise were included.

• Patients were treated with imeglimin 1,000 mg BID orally for 52 weeks as mono- or combination therapy.

• The percentage of patients suffering at least one treatment emergent adverse event was 75.5%, and the majority of these events were mild or moderate in intensity.

• HbA1c reduced by 0.46%, at week 52, with imeglimin monotherapy.

• Use of imeglimin as oral combination therapy was associated with HbA1c reduction by 0.56% - 0.92% at week 52.

• At week 52, HbA1c decreased by 0.12% with injectable glucagon-like peptide 1 receptor agonist combination therapy.

• Use of dipeptidyl peptidase-4 inhibitor in combination with imeglimin provided the greatest net HbA1c reduction (0.92%).