Boehringer Ingelheim and Lilly present full results from EASE Phase III programme for empagliflozin as adjunct to insulin in type 1 diabetes

  • All investigated doses met the primary efficacy endpoint defined as a change from baseline in HbA1c versus placebo after 26 weeks of treatment 
  • Regulatory discussions initiated for empagliflozin, as adjunct to insulin, in type 1 diabetes 
  • Full results presented at the 54th European Association for the Study of Diabetes Annual Congress (EASD) and published online in Diabetes Care ahead of print1
Ingelheim, Germany and Indianapolis, US, 4 October 2018 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today that empagliflozin met the primary efficacy endpoint, defined as a change from baseline in HbA1c versus placebo after 26 weeks of treatment, for all doses investigated (2.5, 10 and 25 mg) in the Empagliflozin as Adjunctive to inSulin thErapy (EASE) Phase III programme in adults with type 1 diabetes. The EASE programme results were published online in Diabetes Care ahead of print and presented at the 54th EASD Annual Congress in Berlin on 4th October, 2018.1
 
Empagliflozin is currently not approved for use in type 1 diabetes.
 
The EASE-2 study evaluated doses of 10 and 25 mg of empagliflozin as adjunct to insulin over 52 weeks, while the EASE-3 study evaluated doses of 2.5, 10 and 25 mg of empagliflozin as adjunct to insulin over 26 weeks. In EASE-2, placebo-corrected mean change from baseline in HbA1c at week 26 was -0.54% and -0.53% for empagliflozin 10 and 25 mg, respectively. In EASE-3 placebo-corrected mean change from baseline in HbA1c at week 26 was -0.28%, -0.45% and -0.52% for empagliflozin 2.5 and 10 and 25 mg, respectively. In addition to reduction in HbA1c, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose.1 
 
In addition, data from continuous glucose monitoring in the EASE programme indicates that patients treated with empagliflozin had improved glycaemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.1
 
There was no increase in the risk of investigator-reported hypoglycaemic events, including severe hypoglycaemia, with empagliflozin treatment, which was a key secondary endpoint in the trials. Additionally, a reduction in patient-reported hypoglycaemic events was observed. The number of adjudicated diabetic ketoacidosis (DKA) events was comparable between empagliflozin 2.5 mg and placebo, and higher than placebo with empagliflozin 10 and 25 mg. Apart from incidence of DKA, the safety profile observed in the EASE programme was generally consistent with the previously reported safety profile of empagliflozin in adults with type 2 diabetes.1 
 
“The goal of the EASE programme was to determine if treatment with empagliflozin could benefit people with type 1 diabetes as an adjunct to insulin,” said Bernard Zinman, M.D., Professor in the Department of Medicine, University of Toronto and Senior Scientist at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada. “Given the risk of DKA for people with type 1 diabetes, the 2.5 mg empagliflozin dose warrants consideration, as it balances glycaemic and metabolic improvements that are relevant to patients without increasing their risk of DKA or other serious adverse events.”
 
Based on the totality of the EASE data Boehringer Ingelheim has initiated regulatory discussions for empagliflozin as adjunct to insulin for adults with type 1 diabetes. 
 
“The EASE programme demonstrated that empagliflozin helps patients with type 1 diabetes to remain within their target glucose range better than insulin alone,” said Dr. Jyothis George, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “There are currently no oral treatment options available for people with type 1 diabetes and these results show that empagliflozin could benefit these individuals. We look forward to working with regulatory authorities to explore whether this potential treatment can be made available to adults with type 1 diabetes.”
 
Jeff Emmick, M.D., Ph.D., Vice President of Product Development for Lilly Diabetes, added: “The Boehringer Ingelheim-Lilly Diabetes Alliance is committed to helping people improve the management of their diabetes, and the EASE programme is part of our broader efforts to explore treatment options that address unmet needs.”
 
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 (link is external)] evaluated 10 and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 52 weeks3 
    Primary endpoint: Change from baseline in HbA1c after 26 weeks of treatment
    Number of patients: 720
  • EASE-3 [NCT02580591 (link is external)] compared 2.5, 10 and 25 mg doses of empagliflozin as adjunct to insulin versus placebo for 26 weeks4
    Primary endpoint: Change from baseline in HbA1c after 26 weeks of treatment
    Number of patients: 960
About 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 (link is external).
 
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 (link is external) and newsroom.lilly.com/social-channels (link is external)
 
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 empagliflozin 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 empagliflozin 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. 

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