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

Ingelheim, Germany and Indianapolis, US, 22 June 2013 - Boehringer Ingelheim and Eli Lilly and Company today 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

“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.

About diabetes
An estimated 371 million people worldwide have Type 1 or Type 2 Diabetes.2 Type 2 Diabetes is the most common type, accounting for an estimated 90–95% of all diabetes cases.³ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.⁴

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three compounds representing several of the largest diabetes treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com  or www.lilly.com.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about €14.7 billion. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programmes and more – to make lives better.

For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about empagliflozin, a potential future treatment for Type 2 Diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that empagliflozin will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.