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Phase III data show significant reductions in blood glucose with investigational compound empagliflozin used as monotherapy in adults with Type 2 Diabetes


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

Boehringer Ingelheim and Eli Lilly and Company has announced results of a 24-week Phase III clinical trial, which showed that treatment with the investigational compound empagliflozin* as monotherapy produced statistically significant reductions in HbA1c (average blood glucose) versus placebo, in patients with Type 2 Diabetes (T2D) who had not received any treatment for at least 12 weeks prior to randomisation.1

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.

Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, the study in patients with T2D (n=899) investigated the safety and efficacy of two doses of empagliflozin (10mg and 25mg) for 24 weeks.1 Results of the primary endpoint showed placebo-adjusted reductions in HbA1c from baseline to week 24 of 0.74% (p<0.001) and 0.85% (p<0.001) for the empagliflozin 10mg and 25mg dose, respectively.1 Sitagliptin 100mg, which was used as an active comparator and not powered for a head-to-head comparison with empagliflozin, showed a placebo-adjusted reduction in HbA1c of 0.73% (p<0.001).1

Study findings at 24 weeks also showed significant improvements with empagliflozin in secondary endpoints:1

  • After 24 weeks, patients treated with empagliflozin 10mg and 25mg showed significant placebo-adjusted decreases in body weight of 1.93kg (p<0.001) and 2.15kg (p<0.001), respectively.1 Sitagliptin 100mg showed a weight increase of 0.5kg versus placebo (p=0.036).1
  • Statistically significant placebo-adjusted reductions in systolic blood pressure of 2.6mmHg (p=0.023) for empagliflozin 10mg and 3.4mmHg (p=0.003) for empagliflozin 25mg.1 Sitagliptin 100mg did not show a statistically significant change in systolic blood pressure versus placebo.1
  • Changes in diastolic blood pressure were only statistically significant for the empagliflozin 25mg arm (1.9mmHg (p=0.030) reduction versus 0.5mmHg reduction for placebo).1

“It is encouraging that these results indicate empagliflozin as monotherapy provided improvements in reducing blood glucose without causing weight gain," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Controlling blood glucose and weight are ongoing challenges for people with Type 2 Diabetes and new treatment options are needed to better manage this progressive condition”.

The proportion of patients reporting adverse events from each study group was 54.9% and 60.5% for empagliflozin 10mg and 25mg, respectively, 61.1% for placebo and 53.4% for sitagliptin 100mg.1 Commonly reported adverse events included hypoglycaemia (plasma glucose ≤70mg/dL and/or requiring assistance – reported by 1 (0.4%) patient per randomised group, none required assistance), as well as adverse events consistent with urinary tract infection (reported in 6.7% and 5.4% of randomised patients on empagliflozin 10mg and 25mg respectively, 5.2% on placebo and 4.9% on sitagliptin 100mg) and genital infection (reported in 3.1% and 4.0% of patients on empagliflozin 10mg and 25mg, respectively, none on placebo and 0.9% on sitagliptin 100mg).1

Additionally, a subset of patients with baseline HbA1c greater than 10% (mean=11.5%, n=87), which was above the study inclusion criteria, were placed on open-label empagliflozin 25mg for 24 weeks and obtained a mean reduction of 3.7% from baseline HbA1c.1 Adverse events were reported by 64.4% of patients included in this subset.

About the study

The 24-week, randomised, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin in drug-naïve patients with T2D. Patients were randomised to receive empagliflozin 10mg (n=224) or 25mg per day (n=224), sitagliptin 100mg per day (n=223), or placebo (n=228) for 24 weeks. Patients with HbA1c more than 10% (n=87) received open-label empagliflozin 25mg per day for 24 weeks. The primary endpoint of the trial was change from baseline HbA1c at week 24. Secondary endpoints were change from baseline in body weight, systolic blood pressure and diastolic blood pressure at week 24.1

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_empagliflozin4.html


MULTIMEDIA AVAILABLE : http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50657361&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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