Fasiglifam (Takeda) success in Phase III trial for treatment of Type 2 Diabetes
Takeda Pharmaceutical Company Limited announced results of a Phase III clinical trial (CCT-003) of fasiglifam (TAK-875) for the treatment of Type 2 Diabetes presented at the 56th Annual Meeting of the Japan Diabetes Society.
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 50 mg (-1.01, 95% CI -1.244; -0.777), respectively, compared to placebo.
Fasiglifam is the first GPR40 agonist to reach late stage (Phase III) clinical development.
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