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ARTICLE | Clinical News

TAK-875: Additional Phase II data

March 5, 2012 8:00 AM UTC

Additional data from a double-blind, international Phase II trial in 426 Type II diabetics who had not responded to metformin or diet and exercise alone showed that once-daily doses of 6.25, 25, 50, 100 and 200 mg TAK-875 significantly reduced mean HbA1c, the primary endpoint, by 0.65-1.12% from baseline to week 12 vs. placebo (p<=0.001 for all). The active comparator glimepiride also significantly reduced mean HbA1c by 1.05% from baseline to week 12 vs. placebo (p<0.0001). Additionally, a greater proportion of patients receiving 50 mg TAK-875 achieved an HbA1c of <7% at week 12 vs. placebo (40.4% vs. 17.6%). There was no significant impact on body weight relative to baseline for any of the TAK-875 dose groups, while glimepiride led to significant weight gain from baseline to week 12 of about 1%. Data were published in The Lancet. ...