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Data From Post-Hoc Analyses Presented at EASD Examine Safety Profile of Linagliptin in Adults with Type 2 Diabetes
Date:9/24/2013

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 24, 2013 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (Lilly; NYSE: LLY) today announced results from two post-hoc, pooled analyses of data from placebo-controlled clinical trials, which examined the safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in adults with type 2 diabetes (T2D). These data were presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD).

Linagliptin, which is marketed as TRADJENTA® (linagliptin) tablets in the U.S., is a once-daily, 5 mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). TRADJENTA has not been studied in patients with a history of pancreatitis, and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA.

General safety analysis 
Findings from a pooled, post-hoc analysis of safety data from 22 linagliptin clinical trials with 7,400 adults with T2D (4,810 received linagliptin, 2,590 received placebo) included the following1:

  • The hypoglycemic incidence rate for linagliptin compared with placebo was 11.5 percent vs. 14 percent, respectively
  • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5 percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent, respectively)

"Drug safety is an important consideration in the selection of appropriate treatments for adults with type 2 diabe
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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