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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

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results of a 52-week phase III clinical trial of the investigational agent empagliflozin*, which showed statistically significant reductions in HbA 1c (average blood glucose) at week 24 with the addition of empagliflozin to existing oral antihyperglycemic therapy in adults with type 2 diabetes (T2D) and mild to moderate kidney impairment (eGFR>/=60 to <90 ml/min/1.73 m 2 and eGFR>/=30 to <60 ml/min/1.73 m 2). 1

Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

Results from the study, presented at the American Diabetes Association 73rd Scientific Sessions ®, also demonstrated a significant reduction in body weight and blood pressure with empagliflozin versus placebo in patients with mild to moderate kidney impairment. 1 Adverse events (AEs) were reported in 79.6 percent, 75.4 percent and 72.7 percent of patients at 24 weeks with empagliflozin 10 mg, empagliflozin 25 mg and placebo, respectively.

"We are encouraged by the data from this phase III study," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Many people with type 2 diabetes also are impacted by renal impairment. Through the Boehringer Ingelheim and Lilly Diabetes alliance, we are using our collective knowledge to find new treatment options for type 2 diabetes."

Results of the study with empagliflozin in patients with renal impairment included:

  • Reductions in HbA 1c for empagliflozin of 0.52 percent and 0.68 percent (p<0.001) for 10 mg and 25 mg, respectively, at week 24 versus placebo in patients with mild renal impairment; for empagliflozin 25 mg, reduction in HbA 1c was 0.42 percent (p<0.001) in patients with moderate renal impairment versus placebo 1

Additionally, results of the study with empagliflozin in patients with renal impairment included the following exploratory endpoints:

  • Decrease in fasting blood glucose (FPG) levels in patients with mild renal impairment of 13.88 mg/dL and 18.08 mg/dL (p<0.001) for empagliflozin 10 mg and 25 mg, respectively, and an increase of 5.67 mg/dL for placebo; in patients with moderate renal impairment, a decrease in FPG levels of 9.26 mg/dL (p<0.001) for empagliflozin 25 mg and an increase of 10.16 mg/dL for placebo 1
  • Loss of 3.88 lbs and 5.14 lbs in body weight for empagliflozin 10 mg and 25 mg, respectively (p<0.001) compared with 0.73 lbs for placebo in patients with mild renal impairment; loss of 2.16 lbs in body weight for empagliflozin 25 mg (p<0.001) compared with 0.176 lbs for placebo in patients with moderate renal impairment 1
  • Improvements in systolic blood pressure (SBP) with empagliflozin versus placebo:
    • In patients with mild renal impairment, SBP decreased by 2.9 mmHg (p=0.033) and 4.5 mmHg (p=0.002) for empagliflozin 10 mg and 25 mg, respectively, while it increased by 0.7 mmHg for placebo
    • In patients with moderate renal impairment, SBP decreased by 3.9 mmHg (p=0.001) for empagliflozin 25 mg and increased by 0.4 mmHg for placebo 1
  • 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.

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