Boehringer Ingelheim and Lilly announce positive top-line Phase III data results for empagliflozin as adjunct to insulin in type 1 diabetes

 
Ingelheim, Germany and Indianapolis, US, 25 June 2018 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that both randomised controlled trials in the EASE phase III programme, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in HbA1c after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10, and 25 mg).
 
Type 1 diabetes currently affects approximately 30 million adults worldwide.1 It is an autoimmune disease in which the body does not produce sufficient amounts of insulin and therefore requires life-long daily insulin administration to regulate blood sugar. For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. People with type 1 diabetes also face risks of complications such as sight loss, heart disease, kidney disease and amputations.  
 
“Despite recent advances in insulin therapy and patient care, optimal glucose control is difficult to achieve in people with type 1 diabetes. Empagliflozin is an effective and well-established medicine used to treat adults with type 2 diabetes, and our comprehensive clinical trial programme continues to investigate the potential benefits it may offer to a range of adults with diabetes”, said Dr. Jyothis George, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “Boehringer Ingelheim and Lilly look forward to sharing the results of the EASE phase III programme at EASD.”
 
The safety profile in both studies was generally consistent with the previously reported safety profile of empagliflozin. The number of adjudicated diabetic ketoacidosis events was comparable between empagliflozin 2.5 mg and placebo and higher than placebo in adults with type 1 diabetes on empagliflozin 10 mg and 25 mg. 
 
The full results from the EASE phase III programme will be presented at the European Association for the Study of Diabetes Annual Meeting on 4th October, 2018 in Berlin, Germany.
 
Empagliflozin is currently not approved for use in people with type 1 diabetes. Boehringer Ingelheim and Lilly are discussing next steps and exploring regulatory options. 
 
About Diabetes
An estimated 425 million adults worldwide have type 1 and type 2 diabetes.2 Type 2 diabetes is the most common form, accounting for around 90 percent of all cases.2 Diabetes is a chronic disease that occurs when the body does not properly produce, or use, the hormone insulin. 
 
About the EASE phase III programme
The EASE phase III programme includes two multinational, double-blinded, placebo-controlled Phase III clinical trials to investigate the efficacy, safety and tolerability of once-daily Empagliflozin as Adjunctive to inSulin thErapy in adults with type 1 diabetes (EASE), an indication for which empagliflozin is currently not approved.
  • EASE-2 [NCT02414958] evaluated 10 mg and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 52 weeks.3 
    Primary endpoint: Change from baseline in HbA1c after 26 weeks of treatment
    Number of patients: 720
  • EASE-3 [NCT02580591] compared 10 mg and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 26 weeks. Additionally, a lower dose of empagliflozin (2.5 mg) was investigated in this trial4
    Number of patients: 960
About SGLT2 inhibitors and empagliflozin
Empagliflozin is an SGLT2 inhibitor which provides blood sugar control with additional benefits of weight loss and lowering blood pressure* in adults with type 2 diabetes. Empagliflozin is the first and only oral diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The benefit-risk profile of empagliflozin has been well-established in its approved indications.
Type 1 diabetes is currently not an approved indication of empagliflozin.
 
About 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 people 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.
 
About Boehringer Ingelheim 
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention. 
Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales. 
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success, rather than short-term profit. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment. 
 
More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.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 wide range of therapies and a continued determination to provide real solutions—from medicines to support programmes 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. 
 
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. 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.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the expansion of clinical trials to evaluate Jardiance as a treatment for adults with type-1 diabetes mellitus and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 
 
CONTACT:
 
Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim 
Phone: +49 (6132) 77 143877
 
Grant Smith 
Manager, Global Business Communications 
Eli Lilly and Company
Phone: +1 (317) 954-9907 

Footnotes

* Jardiance® is not indicated for weight loss or blood pressure reduction.

References

1 International Diabetes Federation. IDF Diabetes Atlas. 8th edn. 2017, Available at: http://diabetesatlas.org/resources/2017-atlas.html
Aug;5(8):597-609. doi: 10.1016/S2213-8587(17)30194-8. Epub 2017 Jun 11.
2 International Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available at: http://www.diabetesatlas.org/. November 2017
3https://clinicaltrials.gov/ct2/show/NCT02414958?term=EASE+Boehringer&rank=2
4https://clinicaltrials.gov/ct2/show/NCT02580591?term=EASE+Boehringer&rank=1