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Results of new exploratory analyses assessing the incidence of hypoglycemia with linagliptin in adults with type 2 diabetes announced
Date:6/22/2013

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from two exploratory analyses assessing the risk of hypoglycemia with linagliptin treatment in adults with type 2 diabetes (T2D).1, 2

In an exploratory analysis of data from two phase III trials, elderly people with T2D (mean age 74 years) treated with linagliptin as add-on to stable basal insulin regimen trended towards a 37 percent and 34 percent lower occurrence of overall hypoglycemia (odds ratio [OR] 0.63 [95 percent confidence interval [CI]: 0.37- 1.10]) and confirmed hypoglycemia (0.66 [0.36-1.21]), respectively, compared with people treated with placebo as add-on to basal insulin.1 Overall hypoglycemia included all investigator-defined hypoglycemic events, while confirmed hypoglycemia was defined as blood glucose levels at or below 70 mg/dL.

In a separate exploratory analysis of two-year data from a phase III trial comparing linagliptin to glimepiride, fewer people treated with the DPP-4 inhibitor linagliptin versus the sulfonylurea glimepiride experienced hypoglycemia (7.5 percent vs. 36.1 percent; p<0.0001).2 After excluding events during dose escalation of glimepiride (1-4 mg in weeks 0-16), a difference in those reporting hypoglycemia still remained present (5.9 percent vs. 25.8 percent; p<0.0001). The difference in the incidence of hypoglycemia between linagliptin and glimepiride was observed at all time points tested, all dose levels, and regardless of change from baseline in HbA1c.2 Hypoglycemia in this analysis was defined as any investigator-reported hypoglycemic event.

At weeks 4, 8, 12, 16 and 104, the percentage of people who experienced a hypoglycemic event was h
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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