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Phase III data show significant reduction in blood glucose with investigational compound empagliflozin added to metformin or metformin plus sulphonylurea in adults with Type 2 Diabetes


June 24, 2013 - Ingelheim, Germany And Indianapolis, United States

For Non-US and Non-UK Media

Boehringer Ingelheim and Eli Lilly and Company has announced results of two Phase III 24-week clinical trials of the investigational compound empagliflozin* added to metformin with and without the addition of sulphonylurea, respectively, in people with Type 2 Diabetes (T2D). These results showed statistically significant reductions in blood glucose among people who received empagliflozin, as measured by reductions in HbA1c (average blood glucose) after 24 weeks.1,2

Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs 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 reducing glucose reabsorption in the kidney.

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

“Metformin is the foundation of treatment for Type 2 Diabetes in people without clinically relevant renal impairment. However, many people don’t meet their blood sugar target due to the progressive nature of the condition and have difficulties managing other risk factors such as weight and increased blood pressure,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The results from this study of empagliflozin as an add-on to metformin or metformin plus sulphonylurea therapies are promising for people with Type 2 Diabetes”.

24-week study with empagliflozin as an add-on to metformin

In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA1c of 0.57% (p<0.001) and 0.64% (p<0.001) for empagliflozin 10mg (n=217) and 25mg (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 of 8mg/dL (p=0.006) with empagliflozin 10mg and 12mg/dL (p<0.001) with empagliflozin 25mg.1 Empagliflozin 10mg and 25mg also had a significant placebo-adjusted reduction in body weight of 1.63kg (p<0.001) and 2.01kg (p<0.001), respectively.1

Further analysis also showed reductions in systolic blood pressure by 4.5mmHg (p<0.001) with empagliflozin 10mg and 5.2mmHg (p<0.001) with empagliflozin 25mg versus placebo.1 Other analysis findings showed reductions in fasting plasma glucose by 20.04mg/dL (p<0.001) with empagliflozin 10mg and 22.28mg/dL (p<0.001) with empagliflozin 25mg versus placebo.1

Adverse events were reported by 57.1% and 49.5% of patients on empagliflozin 10mg and 25mg, respectively, and 58.7% of patients on placebo. Common adverse events included hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported in 1.8% of patients on empagliflozin 10mg, 1.4% on empagliflozin 25mg and 0.5% on placebo, none required assistance), as well as adverse events consistent with urinary tract infection (reported in 5.1% of patients on empagliflozin 10mg, 5.6% on empagliflozin 25mg and 4.9% on placebo) and genital infection (reported in 3.7% of patients on empagliflozin 10mg, 4.7% on empagliflozin 25mg and none on placebo).

24-week study with empagliflozin as an add-on to metformin and sulphonylurea

In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin plus sulphonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64% (p<0.001) and 0.59% (p<0.001) for empagliflozin 10mg (n=225) and 25mg (n=216), respectively, compared with placebo (n=225).2 The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose of 10.02mg/dL (p<0.001) and 13.06mg/dL (p<0.001) with empagliflozin 10mg and 25mg, respectively. Loss of weight greater than 5% was achieved by 27.6% and 23.6% of patients treated with empagliflozin 10mg and 25mg (p<0.001; 1.75kg and 1.99kg), respectively, as add-on to metformin plus sulphonylurea, versus 5.8% on placebo.2

Adverse events were reported by 67.9%, 64.1% and 62.7% of patients on empagliflozin 10mg, 25mg and placebo, respectively. Common adverse events include hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported in 16.1% of patients on empagliflozin 10mg, 11.5% on empagliflozin 25mg and 8.4% on placebo; none required assistance), as well as adverse events consistent with urinary tract infection (reported in 10.3% of patients on empagliflozin 10mg, 8.3% on empagliflozin 25mg and 8.0% on placebo) and genital infection (reported in 2.7% of patients on empagliflozin 10mg, 2.3% on empagliflozin 25mg and 0.9% on placebo).

About the empagliflozin phase III clinical trial programme

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that plans to enrol more than 14,500 patients. This programme comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

*Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_empagliflozin3.html


MULTIMEDIA AVAILABLE : http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50657358&lang=en

CONTACTS : Boehringer Ingelheim GmbH Marco Winkler Product Communication Manager Email: press@boehringer-ingelheim.com Phone: +49 (151) 689 46812 or Lilly Diabetes Tammy Hull Communications Manager Email: hullta@lilly.com Phone: +1 (317) 651 9116

Source: Business Wire India

BusinessWireIndia

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