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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

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 HbA1c (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 m2 and eGFR>/=30 to <60 ml/min/1.73 m2).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
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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