BioCentury
ARTICLE | Clinical News

Empagliflozin: Additional Phase III data

July 1, 2013 7:00 AM UTC

Data from 899 treatment-naïve Type II diabetics with an HbA1c of <=10% in the double-blind, international Phase III Study 1245.20 showed that once-daily empagliflozin led to placebo-adjusted reductions in HbA1c from baseline to week 24, the primary endpoint, of 0.74% in the 10 mg dose arm and 0.85% in the 25 mg dose arm (p<0.001 for both). The active comparator once-daily 100 mg sitagliptin led to a placebo-adjusted reduction in HbA1c from baseline to week 24 of 0.73% (p<0.001). The partners said sitagliptin was used as an active comparator to validate the trial design and not for a head-to-head comparison with empagliflozin.

On secondary endpoints, empagliflozin led to placebo-adjusted reductions in SBP from baseline to week 24 of 2.6 mmHg in the low-dose arm (p=0.023) and 3.4 mmHg in the high-dose arm (p=0.003). Empagliflozin also led to placebo-adjusted reductions in body weight from baseline to week 24 of 4.25 lbs. in the low-dose arm and 4.74 lbs. in the high-dose arm (p<0.001 for both). Additionally, high-dose empagliflozin significantly reduced DBP from baseline to week 24 vs. placebo (1.9 vs. 0.5 mmHg, p=0.03), but low-dose empagliflozin did not significantly reduce the endpoint. In a subset of 87 patients with a baseline HbA1c of >10%, which was above the trial inclusion criteria, open-label 25 mg empagliflozin led to a mean reduction in HbA1c of 3.7% from baseline at week 24. Data were presented at the American Diabetes Association meeting in Chicago. The partners previously reported that both doses of empagliflozin met the primary endpoint vs. placebo (see BioCentury, Jan. 14). ...