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Phase III data show significant reduction in blood glucose with investigational compound empagliflozin added to metformin or metformin plus sulfonylurea in adults with type 2 diabetes
Date:6/22/2013

lt;0.001) for empagliflozin 10 mg (n=225) and 25 mg (n=216), respectively, compared with placebo (n=225).2 The study also showed statistically significant placebo-adjusted reductions at 24 weeks in mean daily glucose concentration of 10.02 mg/dL and 13.06 mg/dL (p<0.001) with empagliflozin 10 mg and 25 mg., respectively. Reductions in body weight were significantly greater with the addition of empagliflozin to metformin plus sulfonylurea (change in body weight of 3.88 lbs, 10 mg; and 4.39 lbs, 25mg; p<0.001).2

Drug-related adverse events were reported by 24.1 percent, 19.8 percent and 15.1 percent of patients on empagliflozin 10 mg, empagliflozin 25 mg, and placebo, respectively. Confirmed hypoglycemia was reported in 16.1 percent of patients on empagliflozin 10 mg, 11.5 percent on empagliflozin 25 mg and 8.4 percent on placebo, none of which required assistance. Adverse events consistent with urinary tract infection were reported in 10.3 percent of patients on empagliflozin 10 mg, 8.3 percent on empagliflozin 25 mg and 8.0 percent on placebo. Adverse events consistent with genital infection were reported in 2.7 percent of patients on empagliflozin 10 mg, 2.3 percent on empagliflozin 25 mg and 0.9 percent on placebo.

About the Empagliflozin Phase III Clinical Trial Program
Empagliflozin is being investigated in adults with T2D in a phase III clinical trial program that has enrolled more than 14,500 patients. This program includes more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

About Diabetes
Approximately 25.8 million Americans3 and an estimated 371 million people worldwide4 have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.3 Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.5 Diab
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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