Imeglimin shows promise for type 2 diabetes
medwireNews: Imeglimin, an agent that improves mitochondrial function, has demonstrated potential as a novel treatment option for Japanese patients with type 2 diabetes in the phase III TIMES 1 and TIMES 3 trials.
Speaking to delegates at the 55th EASD Annual Meeting in Barcelona, Spain, Julie Dubourg (Poxel, Lyon, France) explained that the first-in-class oral agent, which works by increasing insulin secretion and improving insulin sensitivity, previously demonstrated a favorable safety profile and showed efficacy in phase I and IIb trials.
The TIMES (Trials of IMeglimin for Efficacy and Safety) 1 study involved 213 individuals with type 2 diabetes aged an average of approximately 62 years who were randomly assigned to receive imeglimin 1000 mg twice daily or placebo. Average glycated hemoglobin (HbA1c) levels in the imeglimin and placebo groups were 7.99% and 7.93%, respectively.
Dubourg reported that the 106 patients treated with imeglimin experienced a significantly greater reduction in HbA1c levels from baseline to week 24 than the 107 given placebo, with a placebo-adjusted least squares (LS) mean decrease of 0.87%.
The reduction in fasting plasma glucose levels was also significantly greater among patients treated with imeglimin versus placebo (placebo-adjusted LS mean decrease=19 mg/dL), and the presenter said that the agent had consistent efficacy across patient subgroups, including when people were categorized by age and kidney function.
Imeglimin also improved glycemic control when added to insulin treatment in the TIMES 3 study. In line with the TIMES 1 results, Dubourg and colleagues found that reductions in HbA1c levels from baseline to week 16 were significantly greater among the 108 insulin-treated patients given add-on imeglimin compared with the 107 given add-on placebo (placebo-adjusted LS mean decrease=0.60%).
Dubourg said that imeglimin had a “good safety profile” in the phase III studies. In TIMES 1, 44.3% of patients given imeglimin and 44.9% of those given placebo experienced adverse events (AEs), while 2.8% and 5.6%, respectively, experienced AEs leading to treatment discontinuation. In TIMES 3, rates of AEs in the imeglimin and placebo arms were 52.8% and 47.7%, respectively, and a corresponding 0.9% and 3.7% experienced AEs leading to treatment discontinuation.
Together, these findings indicate that “imeglimin is a potential new treatment option as [monotherapy] or add-on therapy in [type 2 diabetes] patients,” concluded Dubourg.
She noted that a global phase III program for the agent is currently undergoing preparation.
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