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Selective GPR40 agonist safe, effective in type 2 diabetes

Issue: August 2011

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ADA 71st Scientific Sessions

SAN DIEGO — Compared with placebo, TAK-875 showed significantly greater reductions in HbA1c at 12 weeks, according to late-breaking data presented here.

TAK-875 is a highly selective G-protein-coupled receptor 40 agonist that has glucose-dependent insulinotropic action with a low risk for hypoglycemia. It is being developed by Takeda as an adjunct therapy to diet and exercise for improving glycemic control in patients with type 2 diabetes.

In a study of 426 patients with diabetes who were randomly assigned to five doses of once-daily TAK-875, ranging from 6.25 mg to 200 mg, all regimens demonstrated significant HbA1c reductions. Decreases in HbA1c produced by TAK-875 >50 mg were comparable to decreases produced by glimepiride (Amaryl, Sanofi-Aventis) at 12 weeks. The researchers noted an apparent plateau at 50 mg and higher. Approximately twice as many patients (33% to 48%) assigned to lower TAK-875 doses of >25 mg achieved HbA1c of 7% or lower at week 12, which was similar to that achieved with glimepiride.

“We have shown for the first time in a clinical efficacy study that TAK-875 works and has significant changes in HbA1c in patients with type 2 diabetes,” Prabhakar Viswanathan, MBBS, PhD, said at the late-breaking clinical studies symposium.

Additionally, changes from baseline in fasting plasma glucose and 2-hour oral glucose tolerance test values observed with TAK-875 were consistent with the changes in HbA1c, the researchers said.

“All doses given over 3 months were well tolerated,” Viswanathan said. Hypoglycemia was significantly lower in all TAK-875 groups (2.3%) compared with placebo (3.3%) and glimepiride (16.1%). Moreover, treatment-emergent adverse events were also low, ranging from 1.6% to 3.3%, and were similar among all active treatment groups.

The study results “are consistent with the glucose-dependent mechanism of action,” the researchers wrote in the study abstract.

For more information:

• Viswanathan P. 134-LBOR. Presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.

Disclosure: Dr. Viswanathan is an employee of Takeda Global Research and Development Center.

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