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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

ster #74-LB, investigators analyzed the data pooled from the same four phase III studies to evaluate events consistent with UTIs and genital infections.2

The safety results with empagliflozin included:

  • Incidence of UTIs comparable to placebo (9.3 percent and 7.5 percent for 10 mg and 25 mg, respectively, vs. 8.2 percent for placebo)2
    • <10 percent of patients experienced more than one event 2
    • Of the reported UTI episodes, most were mild in intensity
      • Mild: 7.5 percent for 10 mg; 6.7 percent for 25 mg, and 6.9 percent for placebo
      • Moderate: 1.7 percent for 10 mg; 0.9 percent for 25 mg, and 1.1 percent for placebo
      • Severe: 0.1 percent for 10 mg; 0 percent for 25 mg, and 0.2 percent for placebo
    • Low discontinuation rates (0.2 percent, 10 mg; 0.1 percent, 25 mg; 0.1 percent, placebo)2
  • Incidence of genital infections higher than placebo (4.2 percent and 3.6 percent for 10 mg and 25 mg, respectively, vs. 0.7 percent for placebo)2
    • <5 percent of patients experienced more than one event2
    • Most episodes were mild (2.9 percent, 10 mg; 2.4 percent, 25 mg; 0.6 percent, placebo) to moderate (1.3 percent, 10 mg; 1.2 percent, 25 mg; 0.1 percent, placebo) in intensity2
    • Low discontinuation rates (0.1 percent, 10 mg; 0.2 percent, 25 mg; 0 percent, placebo)2

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 people. In total, this program includes more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

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