Thursday, May 16, 2013

First in class GPR-40 agonist - Fasiglifam (TAK - 875) , shows positive data in type 2 diabetes

Takeda  announced today the results of a Phase III clinical trial (CCT-003) on its first in class GPR-40 agonist fasiglifam (Development code: TAK-875) for the treatment of type 2 diabetes. The results were presented at the 56th Annual Meeting of the Japan Diabetes Society, being held from the 16th through 18th of May 2013 in Kumamoto, Japan.
The results show that 25 mg and 50 mg fasiglifam , when administered once - daily, showed statistically significant and clinically relevant HbA1c lowering effect in type 2 diabetes patients.
The  phase III randomized, double - blind, placebo - controlled 24 - week study  investigated the efficacy and safety of  once -daily fasiglifam 25mg and 50mg in 192 Japanese patients with type 2 diabetes.  
In the final evaluation at 24 weeks, a statistically significant reduction in HbA1c was found in patients treated with fasiglifam 25 mg (-0.75, 95% CI-0.985;-0.521) and fasiglifam 50mg (-1.01, 95% CI-1.244;-0.777), respectively, compared to placebo.
 In subjects whose HbA1c levels reached the National Glycohemoglobin Standard Program (NGSP) glycemic target of under 6.9% accounted for 30.2%, 54.8%, and 13.8% of the fasiglifam 25 mg, fasiglifam 50 mg, and placebo groups, respectively; the higher percentages vs. placebo arm were statistically significant for both arms of fasiglifam. In addition, in patients with a baseline HbA1c below 8.4%, decreases were 0.41 and 0.62% in the fasiglifam 25mg and fasiglifam 50mg groups, respectively compared to decreases of 1.37and 1.40% in those with a baseline of>8.4%.The study provided additional information regarding safety and tolerability of fasiglifam. Treatment emerging adverse events were mild to moderate, with no significant differences in incidence or types of adverse events between the fasiglifam groups and the placebo group.

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