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Phase III Data Show Significant Reduction In Blood Glucose With Investigational Compound Empagliflozin Added To Metformin Or Metformin Plus Sulfonylurea In Adults With Type 2 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results of two phase III 24-week clinical trials of the investigational agent empagliflozin * added to metformin with and without the addition of sulfonylurea, in people with type 2 diabetes (T2D). The results showed statistically significant improvements in blood glucose as measured by reductions in HbA 1c (average blood glucose) after 24 weeks among people who received empagliflozin. 1,2

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.

The study, presented at the American Diabetes Association 73rd Scientific Sessions ®, also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose concentration and body weight. 1,2 Overall, adverse events were reported in a similar percentage of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo.

"We are particularly encouraged by the blood sugar lowering results of this study with empagliflozin as an add-on to metformin or metformin plus sulfonylurea therapies," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Metformin is commonly the first pharmacological treatment used to treat type 2 diabetes. However, because of the progressive nature of the disease, many patients are not meeting their blood sugar level goals and have difficulties managing other risk factors such as weight and increased blood pressure."

24-week Study with Empagliflozin as Add-on to MetforminIn this 24-week randomized, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA 1c of 0.57 percent and 0.64 percent (p<0.001) for empagliflozin 10 mg (n=217) and 25 mg (n=213), respectively, compared with placebo (n=207). 1 The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose concentration of 8 mg/dL with empagliflozin 10 mg (p=0.006) and 12 mg/dL with empagliflozin 25 mg (p<0.001). 1 Body weight also significantly decreased by 3.6 lbs and 4.4 lbs (p<0.001) with the addition of empagliflozin 10 mg and 25 mg, respectively, compared with metformin.

Drug-related adverse events were reported by 16.1 percent, 12.6 percent, and 12.1 percent of patients on empagliflozin 10 mg, empagliflozin 25 mg, and placebo, respectively. Confirmed hypoglycemia was reported in 1.8 percent of patients on empagliflozin 10 mg, 1.4 percent on empagliflozin 25 mg and 0.5 percent on placebo, none of which required assistance. Adverse events consistent with urinary tract infection were reported in 5.1 percent of patients on empagliflozin 10 mg, 5.6 percent on empagliflozin 25 mg and 4.9 percent on placebo. Adverse events consistent with genital infection were reported in 3.7 percent of patients on empagliflozin 10 mg, 4.7 percent on empagliflozin 25 mg and 0.0 percent on placebo.

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