Aims

To evaluate the efficacy and safety of imeglimin for up to 52 weeks as combination therapy with insulin in Japanese patients with type 2 diabetes.

Materials and Methods

This double-blind, randomized, parallel-group phase 3 trial occurred in 35 sites in Japan. Eligible patients were individuals aged ≥ 20 years with type 2 diabetes and inadequate glycemic control with insulin. Patients were randomly assigned (1:1) to either imeglimin (1000mg BID) or matched placebo, in combination with insulin, for 16 weeks. In a subsequent 36-week, open-label extension period, all patients received imeglimin 1000mg BID. The primary endpoint was the change in mean HbA1c from baseline to week 16.

Results

108 and 107 patients were randomly assigned to treatment with imeglimin 1000mg BID or placebo, respectively. Compared with placebo, the adjusted mean difference in change from baseline HbA1c at week 16 was -0.60% (95% CI -0.80 to -0.40; p<0.0001). This decrease was sustained up to 52 weeks with a mean decrease of -0.64 % (95% CI -0.82 to -0.46) versus baseline. The incidence of patients experiencing adverse events and serious adverse events was similar in both treatment groups. The number of patients experiencing hypoglycemia was similar between treatment groups. In patients receiving imeglimin, all hypoglycemic events were mild in severity; no episodes required assistance.

Conclusions

Imeglimin significantly improved HbA1c in Japanese patients with insufficiently controlled type 2 diabetes by insulin and had a similar safety profile to placebo. The efficacy of imeglimin on top of insulin was sustained for 52 weeks. Imeglimin represents a potential new treatment option for this population as add-on to insulin therapy.

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