Imeglimin, part of a new class of oral agents for type 2 diabetes that target mitochondrial bioenergetics, was found to be safe and effective in Japanese adults, according to results presented at the European Association for the Study of Diabetes Annual Meeting.
Ueki, MD, PhD, director of the Diabetes Research Center at the National Center for Global Health and Medicine in Tokyo, and colleagues conducted a phase 2b randomized, double-blind, placebo-controlled study of imeglimin in Japanese adults with type 2 diabetes (n = 299). Participants were randomly assigned to one of three doses of twice-daily imeglimin (500 mg, 1000 mg and 1500 mg) or placebo for 24 weeks.
At all doses, participants had a significant reduction in HbA1c. The reduction was dose dependent with a 0.52% reduction for 500 mg, 0.94% reduction for 1,000 mg and 1% for 1,500 mg.
At doses of 1,000 mg and 1,500 mg, there was a significant reduction in fasting plasma glucose, glycated albumin and percentage of patients reaching HbA1c below 7%. There was also a dose-dependent reduction in homeostasis model assessment of beta-cell function, as well as decreases in liver enzymes, alanine aminotransferase and gamma-glutamyl transferase.
“The strong efficacy and favorable safety profile of imeglimin observed in this study suggests that it could be particularly well-suited for Japanese patients,” Ueki said in a press release. “Diabetes is a growing health concern in Asia, and imeglimin has the potential to become an innovative new treatment option for Japanese patients to manage their type 2 diabetes.”
A phase 3 study is planned for later this year. – by Cassie Homer
Ueki K, et al. Poster 843. Presented at: European Association for the Study of Diabetes Annual Meeting; Sept. 11-15, 2017; Lisbon, Portugal.
Disclosures: Endocrine Today could not confirm relevant financial disclosures at the time of publication.