Takeda Pharmaceutical Co Ltd has announced encouraging results from a late-stage clinical trial of its investigational diabetes medication fasiglifam.
The Phase III trial data, presented at the recent Japan Diabetes Society, showed that once-daily doses of the oral medicine met its primary endpoint of statistically significantly lowering blood sugar levels in patients with type 2 diabetes, without significant increase in the incidence of hypoglycemia .
More than half (54.8%) of the patients given a 50mg dose and nearly a third (30.2%) of patients taking a 25mg dose of fasiglifam over a 12-week period reduced their HbA1c levels to under 6.9%, compared with 13.8% of patients on a placebo.
Researchers reported mild to moderate adverse effects for the patients, with no significant differences between the fasiglifam groups and placebo.
Kohei Kaku, professor of Kawasaki Medical School who presented the data, described the compound as a “novel glucose-dependent insulin secretagogue with low risk of hypoglycemia”.
He added that if approved, the drug has the potential to become an important new treatment option for type 2 diabetes.
Fasiglifam is the first GPR40 agonist to reach late stage (Phase III) clinical development.
GPR40 is a G protein-coupled receptor highly expressed in pancreatic islet cells. Agonists of the receptor have a mechanism of stimulating insulin release in a glucose-dependent manner, which is different from other classes of diabetes drugs.

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