Positive phase 3 results for Boehringer and Lilly’s diabetes drug

Hannah Blake

pharmaphorum

Boehringer Ingelheim and Eli Lilly have announced positive results for four completed phase 3 clinical trials for their diabetes drug, empagliflozin. The two pharmaceutical companies formed an alliance back in January 2011, in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes.

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D). In these trials, the primary efficacy endpoint was defined as significant change in HbA1c from baseline compared to placebo. This endpoint was met with empagliflozin (10 and 25 mg) taken once daily, in all four trials.

“Boehringer Ingelheim and Lilly are very encouraged by the efficacy and safety results for empagliflozin. 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 relevant treatment option in a new drug class to these patients.”

Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

Empagliflozin is part of a class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. An estimated 371 million people worldwide have diabetes, and T2D is the most common type, accounting for an estimated 90% of all diabetes cases. In clinical trials to date, SGLT2 inhibitors have been shown to reduce blood glucose by removing excess glucose independently of beta cell function and insulin resistance.

The pivotal studies for empagliflozin completed in 2012. Boehringer Ingelheim and Lilly now anticipate filing for regulatory review in the US, Europe and Japan in this year.

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Related news:

Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin (Financial Post)

Boehringer, Lilly Report Positive Top-line Phase III Empagliflozin Results (RTT News)

Reference links:

Boehringer Ingelheim official press release

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