A new type 2 diabetes drug could hit the US market later this year after new data from several late-stage trials showed promising results.
International pharmaceutical companies Eli Lilly and Boehringer Ingelheim announced earlier this week that their experimental drug, empagliflozi, achieved its primary goal of lowering blood sugar levels significantly in patients with type 2 diabetes.
The oral medication was tested at 10 mg- and 25 mg-doses alone and in combination with other common diabetes medicines, such as metformin, against a placebo in four Phase III studies.
Incidence of adverse effects was similar for placebo and both doses of empagliflozi, according to the drugmakers, although genital infections occurred more often with both dosages of the BI/Lilly tablet.
Klaus Dugin, head of medicine at Boehringer Ingelheim, said in a statement: “Many patients with type 2 diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed for them.
“We believe we are now one step closer to bringing a new treatment option to these patients.”
The companies said detailed data from the Phase III trials will be presented at scientific meetings and in publications this year and next, and they plan to file for regulatory approval of empagliflozin in the US, Europe and Japan later this year.
If approved, the sodium glucose co-transporter-2 (SGLT2) inhibitor will compete in Europe with AstraZeneca/Bristol-Myers Squibb’s Forxiga (dapagliflozin), which was turned down by US health regulators last year.
Empagliflozin is just one of several anti-diabetic medications that Lilly and Boehringer are collaborating on under their diabetes drug alliance, which was formed in January 2011.

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