Business Wire

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

Del

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

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181004005237/en/

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] 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] 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.

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

Please click on the following link for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/Empa-T1D-Full-Data

Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Lilly Diabetes and Lilly USA
Greg Kueterman
Director of Communications
Email: kueterman_gregory_andrew@lilly.com
Phone: +1 (317) 432-5195

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Blue Danube Systems Enhances BeamPlanner™ Software Including Artificial Intelligence and Machine Learning Capabilities21.2.2019 20:00:00Pressemelding

Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing new capabilities into its BeamPlanner™ cloud software suite. BeamPlanner is the world’s first network planning and optimization tool for beamforming antenna systems. With the new and enhanced artificial intelligence (AI) and machine learning (ML) functionalities, BeamPlanner becomes the automated platform for network-wide operation of Blue Danube’s Coherent Massive MIMO systems. BeamPlanner utilizes an intelligent analytics-based, data-driven multi-site optimization engine that now has been enhanced with 3D ray tracing capabilities for improved prediction results accuracy. The simulation platform provides actionable beamforming recommendations and expected capacity results matching the real-world performance results validated through drive tests, network statistics data and standard key performance indicators (KPIs). In

Recipients of HCL GRANT 2019 Felicitated by Amitabh Kant & Sourav Ganguly21.2.2019 19:06:00Pressemelding

Mr. Amitabh Kant, CEO, Niti Aayog and Mr. Sourav Ganguly, Former captain of the Indian National Cricket Team felicitated the winners of HCL Grant 2019 at a ceremony held today at HCL Technologies Campus, Noida, in the presence of Mr. Shiv Nadar, Founder & Chairman, HCL, Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies, along with senior dignitaries, bureaucrats, NGO-partners and the HCL leadership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005822/en/ L to R - Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies; Mr. Sourav Ganguly, Former Captain of Indian National Cricket Team; Mr. Amitabh Kant, CEO, NITI Aayog and Ms. Robin Abrams, former president of Palm Computing and longest-serving Board member of HCL Technologies along with the HCL Grant 2019 recipients - Environment - Wildlife Trust of In

International Indigenous Languages Conference Set for June in British Columbia21.2.2019 17:48:00Pressemelding

In celebration of the United Nations 2019 International Year of Indigenous Languages, the First Peoples’ Cultural Foundation (FPCF) and the First Peoples’ Cultural Council (FPCC), in partnership with the Canadian Commission for UNESCO, will host a major international conference on Indigenous language revitalization in British Columbia this summer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005758/en/ WHAT: The HELISET TŦE SḰÁL – ‘Let the Languages Live’ – 2019 International Conference on Indigenous Languages will bring together Indigenous leaders and language experts, speakers, learners and advocates from around the globe to celebrate, honour and share expertise in Indigenous language reclamation, revitalization and maintenance and to learn about successful language projects in B.C. The goal of the conference is to provide participants with practical skills and knowledge to support the Indigenous language revitaliz

Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot21.2.2019 17:00:00Pressemelding

Axilum Robotics, specializing in the development of medical robots, announces that, 2 weeks after the CE mark, the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005667/en/ Axilum Robotics TMS-Cobot (Photo: Business Wire) After having successfully developed and launched outside of the United States (OUS) the TMS-Robot, the first robot designed to assist health care professionals in delivering Transcranial Magnetic Stimulation (TMS), based on an invention of ICube laboratory in Strasbourg, Axilum Robotics has reinforced its expertise in medical robotics with the development of a new platform based on collaborative robot technology. TMS-Cobot, the first medical device built on this platform, allows

myPOS Presented with Best POS Innovation Award by the Merchant Payment Ecosystem21.2.2019 14:57:00Pressemelding

myPOS, one of the fastest growing European payment providers was handed the Best POS Innovation/POS Software Payment Applications award for 2019 by the Merchant Payment Ecosystem (MPE) at a Gala Dinner ceremony in Berlin last night. Being known for offering instant settlement and no-monthly-fees model to SMEs across Europe, myPOS provides a range of innovative features on its payment devices, some of which include Tipping, Payment Request, Top-up and GiftCards. In addition, myPOS merchants are entitled to a whole range of subscription-free, value-added services such as Virtual MO/TO, PayLinks and PayButtons, Checkout module with the most popular shopping carts and more. myPOS clients are also given the opportunity to manage their funds with a free online account and a unique banking platform. The company got nominated in two categories: Best POS Innovation and Best Acquirer of the year, but ultimately won the Best POS Innovation award. "We accept this award with gratitude and appreciat

New Release Crea Records: "ABBA We Love You Forever"21.2.2019 14:44:00Pressemelding

Not many people on this earth can say that they have never heard of ABBA. In addition to the wonderful voices of Agnetha Fältskog and Anni-Fried Lyngstad, the musicians, Björn Ulvaeus and Benny Andersson have written the most wonderful songs, not only composed with charm and elegance, but also so breathtakingly beautiful and unforgettable that they will always resonate. For the Danish singer, BILLBOARD Hot 100 artist, composer and lyricist, Lecia Jonsson, ABBA has been much more than an inspiration. Lecia shared the same melodic universe as ABBA, making her mark with many records as part of duo LECIA & LUCIENNE. Later, as part of another duo, LABAN, Lecia entered BILLBOARD HOT 100 in the United States, had releases in 48 countries worldwide, and sold more than 1.5 million albums. Lecia’s identity is formed by her pure voice and her great sense for writing unique songs filled with a great melodic substance. If anyone should write a song to honour ABBA’s music, Lecia is definitely the pe