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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

not meeting their blood sugar level goals and have difficulties managing other risk factors such as weight and increased blood pressure."

24-week Study with Empagliflozin as Add-on to Metformin
In this 24-week randomized, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA1c of 0.57 percent and 0.64 percent (p<0.001) for empagliflozin 10 mg (n=217) and 25 mg (n=213), respectively, compared with placebo (n=207).1 The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose concentration of 8 mg/dL with empagliflozin 10 mg (p=0.006) and 12 mg/dL with empagliflozin 25 mg (p<0.001).1 Body weight also significantly decreased by 3.6 lbs and 4.4 lbs (p<0.001) with the addition of empagliflozin 10 mg and 25 mg, respectively, compared with metformin.

Drug-related adverse events were reported by 16.1 percent, 12.6 percent, and 12.1 percent of patients on empagliflozin 10 mg, empagliflozin 25 mg, and placebo, respectively. Confirmed hypoglycemia was reported in 1.8 percent of patients on empagliflozin 10 mg, 1.4 percent on empagliflozin 25 mg and 0.5 percent on placebo, none of which required assistance. Adverse events consistent with urinary tract infection were reported in 5.1 percent of patients on empagliflozin 10 mg, 5.6 percent on empagliflozin 25 mg and 4.9 percent on placebo. Adverse events consistent with genital infection were reported in 3.7 percent of patients on empagliflozin 10 mg, 4.7 percent on empagliflozin 25 mg and 0.0 percent on placebo.

24-week Study with Empagliflozin as Add-on to Metformin and Sulfonylurea
In this 24-week randomized, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin plus sulfonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64 percent and 0.59 percent (p&
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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