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Linagliptin recommended for approval in the treatment of type 2 diabetes in Europe
Date:6/24/2011

rnett, clinical director, Department of Diabetes and Endocrinology, University of Birmingham and Heart of England NHS, UK. "Of note, linagliptin is primarily excreted via the bile and gut, meaning no dose adjustment is recommended in patients with kidney or liver impairment. Therefore, this will be the first DPP-4 inhibitor available at one dose for all adult patients with type 2 diabetes."

Linagliptin received a positive opinion based on a clinical trial program which involved approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating linagliptin as monotherapy and in combination with the commonly prescribed oral antihyperglycemic medications, metformin and/or sulfonylurea.  In two monotherapy studies, linagliptin showed a statistically significant mean difference in A1C from placebo of -0.6 to -0.7 percent. In patients who were not adequately controlled on metformin or metformin plus sulfonylurea, the addition of linagliptin also resulted in a statistically significant mean difference in A1C from placebo of -0.6 percent.

"Type 2 diabetes is increasing at an alarming rate worldwide. We are proud that we may soon have the opportunity to offer a new treatment option from our own Boehringer Ingelheim research labs to the millions of European patients with type 2 diabetes whose blood glucose is not adequately controlled," said Prof. Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim.

The CHMP positive opinion for linagliptin marks another regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance, which was formed in January 2011. Linagliptin received approval for use in the U.S. in May 2011.

"We are extremely pleased by the CHMP positive recommendation for approval of linagliptin in Europe," said Enrique Conterno, president of Lilly Diabetes. "Based on our comprehensive studies and the CHMP's positive r
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company
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