The trial’s primary endpoint was to reduce hemoglobin A1c (HbA1c). The proof-of-principle trial demonstrated that metaglidasen had comparable efficacy to currently marketed insulin sensitizers without causing the dose-limiting side effects of edema and weight gain often experienced by patients on those drugs.
The secondary endpoints of lowering triglycerides and uric acid were also met.
“These clinically meaningful data are highly encouraging and merit further study to demonstrate that an insulin sensitizer can be effective in treating patients with type 2 diabetes without posing safety and tolerability issues,” said Dr Mayer Davidson, professor of medicine at UCLA School of Medicine and director of the diabetes program at King-Drew Medical Center.
“By providing comparable efficacy to currently approved products without the usual side effect profile, metaglidasen has the potential to improve the treatment of type 2 diabetes and become a best-in-class drug,” he continued.
“Insulin sensitizers are important because they treat insulin resistance – the underlying cause of type 2 diabetes,” added Dr David Karpf, chief medical officer of Metabolex and clinical associate professor of medicine at Stanford University School of Medicine. “To have a drug that addresses insulin resistance without causing the typically observed side effects of weight gain and edema, which should also predict a lower risk of congestive heart failure, would be a significant advance in the treatment of this common and often debilitating disease.”
Plans for phase III clinical trials of metaglidasen are currently underway.