Long-term safety and efficacy of imeglimin as monotherapy or in combination with existing antidiabetic agents in Japanese patients with type 2 diabetes (TIMES 2): A 52-week open-label, multicenter phase 3 trial

Diabetes, Obesity and MetabolismDubourg J, Fouqueray P, Quinslot D, et al. | December 07, 2021


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%).

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