BioCentury
ARTICLE | Clinical News

Dutogliptin: Phase III data

April 26, 2010 7:00 AM UTC

Top-line data from the double-blind, international Phase III PROT301 trial in 542 patients showed that both doses of once-daily dutogliptin met the primary endpoint of significantly reducing HbA1c from baseline to week 24 vs. placebo. Specifically, 200 and 400 mg dutogliptin reduced HbA1c by 0.28% and 0.59%, respectively, vs. a 0.07% increase for placebo (p<0.0138 and p<0.0001). The 400 mg dutogliptin dose also met all secondary endpoints, including change from baseline in fasting and peak postprandial plasma glucose, change from baseline in glucose AUC over 2 hours after a standard meal test, and percentage of subjects achieving HbA1c <7%. Dutogliptin was well tolerated. Additional Phase III trials evaluating 400 mg dutogliptin in combination with metformin, sulfonylurea and Actos pioglitazone are ongoing. ...