Efficacy and Safety of Imeglimin Monotherapy Versus Placebo in Japanese Patients With Type 2 Diabetes (TIMES 1): A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Trial

OBJECTIVE The aim of this study was to investigate the efficacy and safety imeglimin, first in a new class oral antidiabetic agent, Japanese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This double-blind, randomized, parallel-group, placebo-controlled phase 3 trial 30 sites Japan. Eligible participants were individuals aged ?20 years diabetes treated diet exercise, stable for ?12 weeks prior screening, whose HbA1c 7.0–10.0% (53–86 mmol/mol). Patients randomly assigned (1:1) either imeglimin (1,000 mg twice daily) or matched placebo 24 weeks. Investigators, participants, sponsor remained blinded throughout trial. primary end point change mean from baseline week 24, key secondary percentage responders (according two definitions) at 24. RESULTS Between 26 December 2017 1 February 2019, 106 107 treatment placebo, respectively. Compared adjusted difference ?0.87% (95% CI ?1.04 ?0.69 [?9.5 mmol/mol; 95% ?11.4 ?7.5]; P < 0.0001). Forty-seven (44.3%) reported ?1 adverse event group versus 48 events (44.9%) group. CONCLUSIONS Imeglimin significantly improved compared had similar profile placebo. represents potential option population.