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Phase III data show investigational compound empagliflozin significantly reduced blood glucose in adults with type 2 diabetes
Date:6/22/2013

iflozin 10 mg or 25 mg given for 24 weeks as monotherapy or add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin.1,2 Baseline HbA1c levels were 8.02 percent for the placebo group, 7.98 percent for the empagliflozin 10 mg group, and 7.96 percent for the empagliflozin 25 mg group.1,2

The placebo-adjusted efficacy results at 24 weeks for empagliflozin included:

  • Reductions in HbA1c of 0.62 percent and 0.68 percent (p<0.001) for 10 mg and 25 mg, respectively1
  • Decreases in FPG levels of 27.9 mg/dL and 30.6 mg/dL (p<0.001) for 10 mg and 25 mg, respectively1
  • Loss of 3.99 lbs and 4.43 lbs (p<0.001) in body weight for 10 mg and 25 mg, respectively1
  • Reductions in systolic blood pressure of 3.4 mmHg and 3.8 mmHg (p<0.001) with 10 mg and 25 mg, respectively1
  • Reductions in diastolic blood pressure of 1.2 mmHg and 1.5 mmHg (p<0.001) with 10 mg and 25 mg, respectively1
  • Reductions in uric acid of 0.50 mg/dL and 0.49 mg/dL (p<0.001 vs. placebo) with 10 mg and 25 mg, respectively, versus an increase of 0.02 mg/dL for placebo1
  • Changes in lipid parameters including:
    • LDL cholesterol (bad cholesterol) increased (3.1 mg/dL for 10 mg [p=0.060] and 3.9 mg/dL for 25 mg [p=0.008 vs. placebo]) versus an increase of 0.8 mg/dL for placebo1
    • HDL cholesterol (good cholesterol) increased (2.7 mg/dL for 10 mg and 25 mg; p<0.001 vs. placebo) versus a change of 0.0 mg/dL for placebo1
    • Triglycerides decreased (9.7 mg/dL for 10 mg [p=0.011 vs. placebo] and 1.8 mg/dL for 25 mg [p=0.321]) versus an increase of 2.7 mg/dL for placebo1

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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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