BI 10773 (Boehringer/Eli Lilly) successful in two Phase III trials for Type 2 Diabetes

Two Phase III trials of BI 10773 (empagliflozin), from Boehringer/Eli Lilly, in people with Type 2 Diabetes showed statistically significant improvements in blood glucose. The trials also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose concentration and body weight.

In the first 24-week randomized, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA1c (average blood glucose) of 0.57% and 0.64% for empagliflozin 10 mg and 25 mg, respectively, versus placebo. In the second 24-week trial, adding empagliflozin to a background of metformin plus sulfonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64% (10mg) and 0.59% (25mg) versus placebo. Reductions in body weight were also significantly greater with the addition of empagliflozin to metformin plus sulfonylurea.

The study was presented at the American Diabetes Association 73rd Scientific Sessions. BI 10773 was filed with both the EMA and FDA for Type 2 Diabetes in March 2013.