Mitoglitazone: Phase IIb data
Top-line data from a double-blind, U.S. Phase IIb trial in 266 Type II diabetics showed that once-daily 100 and 150 mg MSDC-0160 each met the primary endpoint of reducing FPG from baseline to week 12 vs. placebo (p=0.006 and p<0.0001, respectively). The once-daily 50 mg dose of MSDC-0160 missed the endpoint, while the active comparator once-daily 45 mg Actos pioglitazone also met the endpoint (p<0.0001). All doses of MSDC-0160 significantly reduced HbA1c from baseline to week 12 vs. placebo. Specifically, the placebo-adjusted mean reductions in HbA1c were 0.39% for low-dose MSDC-0160 (p=0.027), 0.79% for mid-dose MSDC-0160 (p<0.0001) and 0.86% for high-dose MSDC-0160 (p<0.0001). Actos led to a placebo-adjusted mean reduction in HbA1c of 0.98% (p<0.0001). ...