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Phase III study finds investigational agent empagliflozin significantly reduced blood glucose in adults with type 2 diabetes and impaired kidney function
Date:6/22/2013

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  • Improvements in diastolic blood pressure (DBP) with empagliflozin versus placebo:
    • In patients with mild renal impairment, DBP decreased by 1.4 mmHg (p=0.006) and
      2.2 mmHg (p<0.001) for empagliflozin 10 mg and 25 mg, respectively, while it increased by 1.1 mmHg for placebo
    • In patients with moderate renal impairment, DBP decreased by 1.7 mmHg (p=0.020) for empagliflozin 25 mg and increased by 0.2 mmHg for placebo.1
  • The percentage of people with mild renal impairment who reported drug-related AEs at 52 weeks were 37.8 percent, empagliflozin 10 mg; 41.2 percent, empagliflozin 25 mg; and 32.6 percent, placebo. Drug-related AEs at 52 weeks in patients with moderate renal impairment were reported by 27.3 percent, empagliflozin 25 mg; and 24.1 percent, placebo. Observed AEs included hypoglycemia, events consistent with urinary tract infection, events consistent with genital infection, events consistent with volume depletion, and events consistent with bone fracture.

    About the study
    The 52-week randomized, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin as add-on to existing therapy in people with type 2 diabetes mellitus and renal impairment.1 Patients with mild renal impairment received empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Patients with moderate or severe renal impairment received empagliflozin 25 mg or placebo. The primary endpoint was change from baseline in HbA1c at week 24. Exploratory endpoints included changes from baseline in FPG, weight and BP at week 24.1

    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 comprises more than 10 multinational clinical trials, including a l
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    SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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