Imeglimin improves glucose control in type 2 diabetes

In Japanese patients with type 2 diabetes (T2D), use of the novel oral antidiabetic agent imeglimin appears to produce significant improvement in glycated haemoglobin (HbA1c) without increasing the risk of adverse events when compared with placebo, according to the TIMES 1 trial.

TIMES 1 was conducted at 30 sites in Japan. Participants were eligible if they were aged ≥20 years with type 2 diabetes (T2D) treated with diet and exercise, stable for ≥12 weeks prior to screening, and whose HbA1c was 7.0–10.0 percent (53–86 mmol/mol).

A total of 106 and 107 patients were randomly assigned to treatment with oral imeglimin (1,000 mg twice daily) or matched placebo, respectively, for 24 weeks. Investigators, participants, and the study sponsor remained blinded throughout the trial.

The primary outcome of the change in mean HbA1c at week 24 from baseline was significantly greater in the active treatment group versus the placebo group (adjusted mean difference, −0.87 percent (95 percent confidence interval [CI], −1.04 to −0.69 [−9.5 mmol/mol, 95 percent CI, −11.4 to −7.5]; p<0.0001).

There were 47 (44.3 percent) patients who experienced ≥1 adverse event in the imeglimin group. This number was similar to the 44.9 percent recorded in the placebo group.

The findings indicate that imeglimin represents a potential new treatment option for patients with T2D.