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Boehringer, Lilly Report Positive Top-line Phase III Empagliflozin Results

Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced top-line results for four completed Phase III trials for empagliflozin, an investigational sodium glucose co-transporter-2 or SGLT-2 inhibitor being studied for type 2 diabetes or T2D treatment.

The company said that incidence of adverse events was similar for placebo, empagliflozin 10mg and 25mg, while genital infections occurred more often with empagliflozin compared with placebo. This safety information is consistent with findings reported in the Phase II trial results for empagliflozin.

Empagliflozin is being investigated in adults with T2D in a Phase III study program, which would enroll more than 14,500 patients. Totally, this program consists of eight multinational trials, including a large cardiovascular outcome trial. The pivotal studies for empagliflozin completed in 2012, and Boehringer Ingelheim and Lilly anticipate filing for regulatory review in the U.S., Europe and Japan in 2013. Boehringer Ingelheim and Lilly intend to present detailed data disclosures for many of these studies at scientific medical meetings and publications in 2013 and 2014.

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