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Efficacy and safety of imeglimin in Japanese patients with type 2 diabetes mellitus: A 24‐week, randomized, double‐blind, placebo‐controlled, dose‐ranging phase 2b trial

Diabetes, Obesity and Metabolism Dec 16, 2020

Dubourg J, Ueki K, Grouin JM, et al. - In this 24‐week, randomized, double‐blind, placebo‐controlled, parallel group, dose ranging, phase 2b clinical trial, researchers sought to evaluate the effectiveness and safety of imeglimin monotherapy compared with placebo for 24 weeks in Japanese patients with type 2 diabetes mellitus (T2DM). Eligible for inclusion were Japanese adults (age ≥ 20 years) with T2DM either treatment‐naïve or previously treated with one oral anti‐diabetes agent. Study participants were randomly assigned (1:1:1:1) to obtain orally imeglimin 500 mg or imeglimin 1,000 mg or imeglimin 1,500 mg, or placebo twice daily over a 24‐week period. In total, 299 patients were randomized to receive double‐blind treatment with orally twice‐daily placebo (n =  75), imeglimin 500 mg (n = 75), 1,000 mg (n = 74) or 1,500 mg (n = 75). The authors concluded that imeglimin as monotherapy was well tolerated and significantly improved glycemic control in Japanese patients with T2DM, with no significant increase in hypoglycemic events vs placebo. Due to a marginal increase in efficacy at the 1,500 mg vs 1,000 mg dose (along with the potential for gastrointestinal tolerability issues), a dose of 1,000 mg BID was chosen for subsequent Phase III studies.

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