ITCA 650: Phase III data

Top-line data from the double-blind, international Phase III FREEDOM-2 trial in 535 Type II diabetics with an HbA1c of 7.5-10.5% showed that once-daily 60 ug ITCA 650 met the primary endpoint of reducing HbA1c from baseline to week 52 vs. once-daily 100 mg oral Januvia sitagliptin (1.5% vs. 0.8%, p<0.001). ITCA 650 also met the secondary endpoints of a greater proportion of patients achieving an HbA1c of <7% at week 52, a greater proportion of patients with both a reduction in HbA1c of >0.5% and weight loss of >=2 kg, and a greater reduction in body weight (4 vs. 1.3 kg, p<0.001) vs. Januvia. No cases of major hypoglycemia were reported. Patients were also on background metformin therapy. ...