Boehringer Ingelheim: Phase III clinical trial found that empagliflozin in combination with metformin reduces blood glucose levels in adults with type 2 diabetes

• Initial combinations of empagliflozin and metformin in patients with T2D led to significant reductions in blood glucose vs. empagliflozin or metformin alone at 24 weeks

Ingelheim, Germany and Indianapolis, US, 8-6-2015 — /EuropaWire/ — A Phase III clinical trial has found that empagliflozin in combination with metformin reduces blood glucose levels in adults with type 2 diabetes (T2D). Boehringer Ingelheim and Eli Lilly and Company presented these findings in a late-breaking poster at the American Diabetes Association’s (ADA) 75th Scientific Sessions®. The 24-week study compared dual therapy of empagliflozin and metformin to monotherapy of either empagliflozin or metformin in patients with T2D.1

“The American Diabetes Association recommends a blood sugar level below seven percent for many people with type 2 diabetes and we are encouraged that more adults achieved HbA1c levels lower than 7.0 percent after 24 weeks in the empagliflozin and metformin combination group than either the metformin or empagliflozin group,” said Professor Hans-J. Woerle, Vice President, Head of Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim.

The HbA1c test, expressed as a percentage, provides a measure of average blood sugar levels over the past two to three months.

The primary endpoint of this study of 1,364 randomised adults with T2D was change from baseline in HbA1c at 24 weeks. Patients enrolled in this study were not receiving any glucose lowering therapy for at least 12 weeks prior to the start of the trial and had a mean baseline HbA1c of approximately 8.7 percent.1

All four empagliflozin and metformin combination doses showed statistically significant reductions in HbA1c vs. the individual components of empagliflozin or metformin. Statistical models showed the following estimated average HbA1c level reductions from baseline:1

• Empagliflozin 12.5 mg bid/metformin 1000 mg bid: 2.08 percent
• Empagliflozin 12.5 mg bid/metformin 500 mg bid: 1.93 percent
• Empagliflozin 5 mg bid/metformin 1000 mg bid: 2.07 percent
• Empagliflozin 5 mg bid/metformin 500 mg bid: 1.98 percent
• Empagliflozin 25 mg qd: 1.36 percent
• Empagliflozin 10 mg qd: 1.35 percent
• Metformin 1000 mg bid: 1.75 percent
• Metformin 500 mg bid: 1.18 percent

Changes from baseline in fasting plasma glucose (FPG) and weight were exploratory analyses. Patients in this study had a mean baseline FPG of approximately 169.6 mg/dL. The empagliflozin and metformin combinations resulted in larger reductions in FPG versus either empagliflozin or metformin alone. The empagliflozin and metformin combinations also resulted in a statistically significant reduction in weight versus metformin monotherapy.1

The overall frequency of adverse events (AEs) was consistent across all patient groups (56.7 – 66.3 percent). The percentage of patients with confirmed hypoglycaemic AEs (glucose ≤70mg/dL and/or requiring assistance) was low in all groups (0-1.8 percent); none required assistance.1

Initial combination treatment with empagliflozin and metformin was part of an investigational trial. The fixed dose combination of empagliflozin and metformin hydrochloride (Synjardy®) was approved for the treatment of T2D in adults on 27 May 2015 in the European Union, but is not approved for first line use.2

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about the global business of the Diabetes Alliance. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.boehringer-ingelheim.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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

This press release contains forward looking statements about Synjardy®. 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 commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that Synjardy® will be commercially successful, or that it will receive additional regulatory approvals. 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. Except as required by law, Lilly undertakes no duty to update forward-looking statements.

REFERENCES

1. Hadjadj S, et al. Initial combinations of empagliflozin and metformin (empa+met) in patients with type 2 diabetes (T2DM). Poster No 119-LB Presented at the American Diabetes Association® (ADA) 75th Scientific Sessions June 5-9, Boston, MA. 2015.
2. Synjardy® (empagliflozin/metformin HCl) tablets. EMA Summary of Product Characteristics. Approval 27 May 2015.

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Professor Hans-J. Woerle, Vice President, Head of Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim