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FDA Approves Tradjenta™ (linagliptin) Tablets for the Treatment of Type 2 Diabetes
Date:5/2/2011

RIDGEFIELD, Conn. and INDIANAPOLIS, May 2, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved Tradjenta™ (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.  

TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With TRADJENTA, no dose adjustment is recommended for patients with kidney or liver impairment. TRADJENTA is a tablet that can be taken with or without food. TRADJENTA lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.  

"Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications," said John Gerich M.D., professor of medicine, University of Rochester School of Medicine. "The FDA approval of TRADJENTA is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. W
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company
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