Boehringer Ingelheim and Lilly present full results of Trajenta®’s CARMELINA® cardiovascular outcome trial
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today presented the full results of the long-term cardiovascular outcome trial, CARMELINA®, which studied the impact of Trajenta® (linagliptin) on cardiovascular and kidney safety in adults with type 2 diabetes at high risk for heart and/or kidney disease.1,2 The study met its primary endpoint,* with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.1 CARMELINA® also included a key secondary composite endpoint,† showing a similar kidney safety profile compared to placebo.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181004005553/en/
The overall safety profile of linagliptin in CARMELINA® was consistent with previous data and no new safety signals were observed.1 CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.1
The full results were presented at the 54th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.
“Heart disease is a major complication and the leading cause of death for people living with type 2 diabetes. CARMELINA® adds important new evidence for type 2 diabetes patients at high risk of heart and/or kidney disease, a population that has been underrepresented in other cardiovascular outcome trials, but whom we see in our daily practice. The trial confirmed that linagliptin can be used with confidence in this patient population,” commented 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.
In CARMELINA®, cardiovascular events that contributed to the primary endpoint* occurred in 12.4 percent (434 people) of the linagliptin group compared to 12.1 percent (420 people) in the placebo group, demonstrating a similar long-term cardiovascular safety profile in adults with type 2 diabetes.1 Linagliptin also showed a similar long-term kidney safety profile compared to placebo. This was demonstrated on the composite endpoint reflecting declining kidney function† occurring in 9.4 percent (327 people) of the linagliptin group compared to 8.8 percent (306 people) of the placebo group.1
An increase in the risk of hospitalisation for heart failure has been observed in some other cardiovascular outcome trials in diabetes.3,4 In CARMELINA®, this endpoint was pre-specified and assessed thoroughly via adjudication.‡ Hospitalisation for heart failure occurred in 6 percent (209 people) of the linagliptin group compared to 6.5 percent (226) of the placebo group.1 “These results are particularly meaningful given the patient population in CARMELINA, including those most vulnerable to developing heart failure,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“While many guidelines5,6 now recognise the importance of choosing a diabetes treatment with a proven benefit on reducing cardiovascular risk and mortality in people with type 2 diabetes and heart disease, there remains a need for additional glucose-lowering options,” Waheed Jamal pointed out. “CARMELINA® reinforces confidence in linagliptin as an effective and well-tolerated treatment, with a simple dosing regimen for adults with type 2 diabetes.”
“We have created a unique cardiovascular outcome trial programme for linagliptin with two trials — CARMELINA®, whose results are released today, as well as CAROLINA®, which will report initial results in the near future,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “This programme will provide clinical data on the long-term safety profile of linagliptin in a broad range of adults with type 2 diabetes, which reflects patients that doctors see in their daily practice.7”
CARMELINA® is a multi-national, randomised, double-blind, placebo-controlled clinical trial that involved 6,979 adults with type 2 diabetes from 27 countries at more than 600 sites observed for a median duration of 2.2 years.2,8 The study was designed to assess the effect of linagliptin (5mg once daily) compared to placebo (both added to standard of care) on cardiovascular outcomes in adults with type 2 diabetes and high cardiovascular risk, the majority of whom also had kidney disease.2,8 This population of people with high risk of cardiovascular and/or kidney disease reflects patients that doctors see in their daily practice.7 Standard of care included both glucose lowering agents and cardiovascular drugs (including antihypertensive and lipid lowering agents).
CARMELINA® was led by an academic trial steering committee and the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance. Compared to other recently reported outcome trials of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes, CARMELINA® included the highest number of patients with impaired kidney function.§
To learn more about CARMELINA®, please visit: https://www.carmelinatrial.com/
Trajenta® is a one dose, once daily DPP-4 inhibitor that provides significant efficacy in the reduction of blood sugar levels for adults with type 2 diabetes. It can be prescribed for adult patients with type 2 diabetes regardless of age, disease duration, ethnicity, body mass index (BMI), liver and kidney function.9 Trajenta® has the lowest kidney excretion rate of all DPP-4 inhibitors.9-13
About our cardiovascular outcome trials
As cardiovascular disease is a major complication and the leading cause of death in type 2 diabetes,14 cardiovascular safety of all type 2 diabetes treatments is important. Worldwide, most people with type 2 diabetes die of a cardiovascular event.15 In 2015, Boehringer Ingelheim and Eli Lilly and Company announced results from the landmark cardiovascular outcome trial EMPA-REG OUTCOME® with the SGLT2 inhibitor empagliflozin.16,17
CARMELINA® is one of two cardiovascular outcome trials with the DPP-4 inhibitor linagliptin. CAROLINA®,18 will be the first DPP-4 inhibitor cardiovascular outcome trial to compare commonly used second line treatments — linagliptin and the sulphonylurea glimepiride. This trial includes adults with relatively early type 2 diabetes and increased cardiovascular risk or established complications, with less than optimised blood sugar control. The majority did not yet have heart and kidney disease. The study will report initial results in the near future. CARMELINA® and CAROLINA® will provide clinical data on the long-term safety profile of linagliptin in a broad range of adults with type 2 diabetes, which reflects patients that doctors see in their daily practice.7
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/CARMELINA
* Primary endpoint defined as time to first occurrence of the 3-P MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke)
† Key secondary endpoint defined as time to first occurrence of sustained end stage kidney disease (ESKD), death due to kidney disease, or a sustained decrease in eGFR from baseline of ≥40 percent compared to placebo
‡ Assessed by an independent clinical event committee in a blinded way
§ Glomerular filtration rate below 30 mL/min/m2
Phone: +49 (6132) 77 2012
Lilly Diabetes and Lilly USA
Gregory Andrew Kueterman
Director of Communications
Phone: +1 (317) 432-5195
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
IWBI Launches Global Network of Advisors for WELL Portfolio16.10.2018 21:00 | Tiedote
The International WELL Building Institute™ (IWBI™) today announced the formation of a global advisory to help shape and advance the implementation of the WELL Portfolio™ Pathway pilot, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. WELL Portfolio, announced this past month, is being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™). It is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The advisory includes a collection of professionals, practitioners and experts across a range of industries and sectors, each serving a one-year term. “Since we launched WELL, we’ve seen an explosion of interest from global companies to bring the same health and wellness benefits across thei
The X7 Delivers Right-sized Packaging Automation from Packsize While Reducing Labor, Shipping, and Material Costs16.10.2018 20:55 | Tiedote
The continued decline in unemployment is impacting companies across nearly every industry; a reported 3.7 percent national average in September by the U.S. Department of Labor. Heightened demand for goods ordered over the internet amplifies the worker shortage for these companies shipping products. To ensure optimal and timely outcomes and smart industry improvements for its customers, Packsize today announces its fully automated, right-sized packaging system, the X7™. The new automated custom box-making system represents a significant investment by Packsize in machine learning, packaging process automation, corrugated infrastructure and testing, and business intelligence. The automated system is the second in the company’s X Series line of automated, On Demand Packaging® technology solutions. Advancing packaging automation for complex, single- and multiple-item orders, the X7™ achieves sustainability and supply chain workflow optimization. Delivering the most needed functions to make,
Event Software Company Aventri Acquires ITN International16.10.2018 19:00 | Tiedote
Leading event management software company Aventri announced the acquisition of ITN International, the industry leader in NFC, mobile and cloud-based technology. With the acquisition of ITN, Aventri will broaden its technology and service offerings, expanding its global reach and the events that they support. Servicing annually 125 events, 10,000 exhibitors and 1.5 million attendees, ITN serves event producers by combining technology with personalized professional services to optimize events. A look at their product set includes: Online registration system with speaker management, agenda builder, session scheduling, and more. Onsite services include NFC badges, check-in stations, lead retrieval, apps, RFID scanning and more. Data visualization tools with advanced reporting and analytics around registration, badge activity and scans. “The acquisition of ITN as a global provider of cloud-based event management solutions is a major growth opportunity for Aventri,” says Oni Chukwu, CEO of A
Thales and Gemalto Are Granted Regulatory Clearance from the Competition Commission in South Africa16.10.2018 19:00 | Tiedote
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received Regulatory Clearance from the Competition Commission in South Africa. Together with the antitrust clearances obtained in China, Israel and Turkey, and clearances relating to foreign investments in Australia, Canada and the USA (CFIUS), Thales and Gemalto have now obtained 7 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with
Piraeus Bank Finances the Development of Thriassio Transit Center16.10.2018 18:39 | Tiedote
Piraeus Bank will finance the development of the Thriassio Transit Center, which will help increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. The Center will significantly increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. It will contribute to the provision of upgraded services while also reducing transport costs, which are key factors in lowering the final price of products, having a direct positive impact on the competitiveness of the economy and GDP growth. The project is also expected to boost local employment, creating up to 5,000 jobs over the next 10 years. The new Thriasio Transit Center is expected to become operational in 2024. Piraeus Bank Chief Executive Officer, Mr. Christos Megalou said: “Piraeus Bank are always looking for suitable investment projects that align with our strategy to be a pillar of stability for the Greek economy and we ar
Inside Secure’s Latest Whitebox Software Security Tool Brings Mobile Developers New Levels of Protection, Performance and Control16.10.2018 18:36 | Tiedote
Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, today announced general availability of its Whitebox 3.0 software crypto-security tool that protects cryptographic keys and algorithms inside mobile applications that demand top-notch security. Inherently running in an exposed environment, mobile applications are susceptible to attackers who can then see all the secrets within the app. As a proven innovator in software security, Inside Secure builds on numerous years of successful integrations for top developers to offer the best technology for hiding data and cryptography on mobile devices. Serving as an appealing alternative to an expensive, hardware-dependent Trusted Execution Environment (TEE) or Secure Element (SE) Whitebox 3.0 secures assets with uniquely powerful features that bring industry-changing gains in performance and flexibility – key traits that developers demand. Inside Secure’s pure software approach means
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme