The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in A1C after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10 and 25 mg).
| RIDGEFIELD, Conn. and INDIANAPOLIS, June 25, 2018 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that both randomized controlled trials in the EASE Phase III program, 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 A1C after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10 and 25 mg). Type 1 diabetes currently affects 1.3 million adults in the U.S. and approximately 30 million adults worldwide. 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, less than one third of adults with type 1 diabetes in the U.S. consistently meet target blood sugar levels,” noted Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs - Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “The EASE trials are part of our comprehensive clinical development program exploring how empagliflozin may improve patient health outcomes and fill treatment gaps for adults with and without type 2 diabetes, and we look forward to sharing the full results from both trials.” 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 program will be presented at the European Association for the Study of Diabetes Annual Meeting on October 4, 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 About the EASE Phase III Program
About Empagliflozin Boehringer Ingelheim and Eli Lilly and Company About Boehringer Ingelheim Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives. In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales. For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. About Lilly Diabetes About Eli Lilly and Company 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 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. P-LLY CONTACT: Grant Smith
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