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

• 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.

• Treatments employed for these patients included: imeglimin monotherapy (n = 134), combination with an α-glucosidase inhibitor (n = 64), biguanide (n = 64), dipeptidyl peptidase-4 inhibitor (DPP4-I; n = 63), glinide (n = 64), glucagon-like peptide-1 receptor agonist (GLP1-RA; n = 70), sodium-glucose co-transporter-2 inhibitor (n = 63), sulphonylurea (n = 127), or thiazolidinedione (n = 65).

• At least one treatment emergent adverse event (TEAE) occurred in 75.5% of patients, and the majority of these events were mild or moderate in intensity.

• In 5.6% of all patients, occurrence of serious TEAEs, none of them related to the study drug, was evident.

• None of the groups showed clinically significant changes in ECG, vital signs, physical examination, or laboratory tests.

• Imeglimin monotherapy, imeglimin as oral combination therapy, and injectable GLP1-RA combination therapy brought about HbA1c reduction by 0.46%, 0.56%-0.92%, and 0.12%, respectively, at week 52.

• Patients treated with a DPP4-I in combination with imeglimin showed the greatest net HbA1c reduction (0.92%).