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
Om Business Wire
(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
Transphorm Strengthens 900 V GaN Portfolio with Second FET25.6.2019 13:00:00 CEST | Pressemelding
Transphorm Inc.—the leader in the design and manufacturing of the highest reliability high-voltage (HV) Gallium Nitride (GaN) semiconductors—today introduced its second 900 V FET, the Gen III TP90H050WS, enhancing the industry’s only 900 V GaN product line. These devices now enable three-phase industrial systems and higher voltage automotive electronics to leverage GaN’s speed, efficiency and power density. Further, the new FET’s platform is based on Transphorm’s 650 V predecessor, the only JEDEC- and AEC-Q101-qualified HV GaN technology. As such, system developers can design with confidence in its quality and reliability. The TP90H050WS has a typical on-resistance of 50 mOhm with a 1000 V transient rating, offered in a standard TO-247 package. The TP90H050WS can reach power levels of 8 kW in a typical half bridge while maintaining greater than 99 percent efficiencies. Its figures of merit for Ron*Qoss (resonant switching topologies) and Ron*Qrr (hard switching bridge topologies) are t
Modern Governance 3.0: Modern Governance Extends Beyond the Boardroom to Allow Secure Sharing of Files and Collaboration with Auditors, Regulators and Other Third Parties25.6.2019 13:00:00 CEST | Pressemelding
In its next major extension to support modern governance, Diligent announced today the launch of Secure File Sharing and Secure Meeting Workflow applications, as part of the Diligent Governance Cloud. These groundbreaking applications enable completely secure collaboration not only between board members and executives, but also reaching beyond the boardroom including auditors, regulators and other key third party stakeholders. This significantly raises the bar on security and information governance for organizations operating in this digital, mobile and social era. In today’s fast-paced world, threats come at light speed – from every angle. Leading organizations must set increasingly higher standards to protect against cyber attacks and leaks, while at the same time work collaboratively with more outside parties. Even competent leaders can have blind spots when it comes to the handling of highly sensitive files, specifically in preparation for a board meeting, sharing documents haphaza
Moody’s Analytics CreditLens™ Solution Adopted by Over 100 Firms25.6.2019 13:00:00 CEST | Pressemelding
Moody’s Analytics, a leading provider of financial intelligence, announced today that the CreditLens credit-lifecycle-management solution has been adopted by over 100 firms since its launch. Built on the latest cloud-based technology, the CreditLens platform helps businesses digitally transform their commercial credit processes to make faster and better-informed decisions. The platform uses the latest AI and machine learning technology to facilitate process automation, and help clients improve efficiency, reduce errors, and streamline workflows. "We are honored that our clients have embraced the CreditLens solution and enabled us to reach this milestone,” said Annie Choi, Senior Director at Moody’s Analytics. “Our goal is to provide the best credit lifecycle management solution in the market, informed by our award-winning proprietary data, and enabled by the modern technologies our clients want to use.” “Technological innovation is accelerating at a rapid pace, creating opportunities f
BOC Group Announces the Release of ADONIS NP 7.1 – Igniting A New Era of User Inclusion, Insights & BPM Experience25.6.2019 12:26:00 CEST | Pressemelding
Today, BOC Group released the latest version of its revolutionary BPM suite, ADONIS NP 7.1. Focusing specially on enriching the ADONIS NP experience for every user, transparency, simplicity and openness were kept at the core of this version’s design. And this release’s flagship feature, the Process Insights Dashboard, is a direct embodiment of that, with its powerful visualization and representation of all key process management information. Tobias Rausch, ADONIS NP product manager, elaborates: “We carefully designed the Insights Dashboard in a way that provides that one-click-access to everything you would need to know about your processes – from process hierarchy, responsible roles, inputs, outputs, to IT, risks, KPIs, as well as quick-links to analyses and reports”. “Essentially, the Insights Dashboard brings an entirely new and simplified way of interacting with the process content, ultimately making ADONIS NP even more user-friendly and intuitive than befo re!" What’s more, the la
MATRIXX Software Joins Linux Foundation Networking to Advance Next Generation of Telco Services25.6.2019 12:05:00 CEST | Pressemelding
MATRIXX Software , an innovation powerhouse committed to transforming global commerce, today announced it has joined Linux Foundation Networking (LFN) as a silver member. MATRIXX is participating in the foundation’s programs to provide guidance related to advancing a new generation of services inspired by web-scale best practices. With over 100 members, LFN continues its global drumbeat of ecosystem growth for accelerated development and adoption of open source and open standards-based networking technologies. The Linux Foundation supports the creation of sustainable open source ecosystems by providing financial and intellectual resources, infrastructure, services, events and training. “The LF Networking community is working together to foster industry collaboration and innovation across the entire open networking stack, and increase harmonization across platforms, ecosystems and communities,” said Arpit Joshipura, general manager, Networking, Automation, Edge & IOT, the Linux Foundati
Patient Safety Movement Foundation Announces First Curriculum Commitments25.6.2019 12:00:00 CEST | Pressemelding
To advance the education of healthcare professionals and reduce the number of preventable deaths, the Patient Safety Movement Foundation (PSMF) has developed core curriculum to teach patient safety throughout the entire education process, from freshman year through residency. The continued education and development of healthcare students and professionals improves the quality of patient care and eliminates preventable medical error. By committing to the Patient Safety Curriculum (Actionable Patient Safety Solutions #17), participants commit to: Improve knowledge of the science, as well as the human side, of patient safety Gain skills required to apply safe care practices to reduce medical error Value the role of patients and families as members of the healthcare team Demonstrate effective personal and team behaviors that support a just culture and reliable health system performance Advance the goal of eliminating preventable patient deaths “Helping healthcare students and professionals