Full data from CAROLINA® outcome trial support long-term cardiovascular safety profile of Trajenta®
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA® trial demonstrating that Trajenta® (linagliptin) did not increase cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk.1 The findings were reported today at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190610005823/en/
The trial met its primary endpoint, defined as non-inferiority for linagliptin versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE), which occurred in 11.8 percent (356 people) of the linagliptin group compared to 12.0 percent (362 people) of the glimepiride group.1 The overall safety profile of linagliptin in CAROLINA® was consistent with previous data, and no new safety signals were observed.1,2
The study assessed linagliptin safety over the longest period ever studied in a DPP-4 inhibitor cardiovascular outcome trial, with a median follow-up of more than 6 years.1 Linagliptin was similar to glimepiride in the secondary endpoint of 3P-MACE plus hospitalisation for unstable angina (4P-MACE - 13.2 percent for linagliptin versus 13.3 percent for glimepiride).1
In CAROLINA®, a higher proportion of patients within the linagliptin group (16.0 percent) achieved the secondary composite efficacy endpoint of treatment sustainability versus the glimepiride group (10.2 percent).*1 Compared with glimepiride, linagliptin demonstrated similar overall effects on HbA1c, but significantly reduced the relative risk for hypoglycaemia (low blood sugar) by 77 percent (10.6 percent of patients treated with linagliptin experienced any hypoglycaemic incident versus 37.7 percent for glimepiride).1 This risk reduction was consistent and significant across all hypoglycaemia categories, including severe hypoglycaemia and those requiring hospitalisation. Linagliptin was also associated with a modest weight reduction of 1.5 kg versus glimepiride.1
“CAROLINA® is unique in that it is the only DPP-4 inhibitor cardiovascular outcome trial with an active comparator,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim. “When additional glucose-lowering is needed, DPP-4 inhibitors and sulfonylureas continue to be frequently used as add-on therapies to metformin. These data can further support physicians in choosing the most appropriate glucose-lowering treatment for each individual patient.”
“The American Diabetes Association and European Association for the Study of Diabetes recommend type 2 diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes. “But, physicians considering additional therapies to lower blood glucose for their patients need a DPP-4 inhibitor with an established long-term safety profile. These new data from CAROLINA®, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA®, expand the evidence and experience with linagliptin, to provide healthcare professionals with confidence in the long-term safety profile across a broad range of patients with type 2 diabetes.”
CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) is a multi-national, randomised, double-blind, active-controlled clinical trial that involved 6,033 adults with type 2 diabetes from 43 countries at more than 600 sites observed for a median duration of more than 6 years.3,4 The trial included adults with early type 2 diabetes: adults with a median disease duration of 6.2 years, who either received no treatment at all, or received 1-2 glucose lowering agents (e.g. metformin).4 It was designed to assess the effect of Trajenta® (linagliptin) (5 mg once daily) compared to the sulphonylurea glimepiride (both added to stable background glucose-lowering medication and cardiovascular standard of care) on cardiovascular safety in adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease.3,4 These people reflect patients that doctors typically see in their daily clinical practice.5
CAROLINA® was led by an academic trial steering committee and Boehringer Ingelheim and Eli Lilly and Company. CAROLINA® is the only DPP-4 inhibitor, active-comparator cardiovascular outcome trial.
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 adults with type 2 diabetes regardless of age, disease duration, ethnicity, body mass index (BMI), liver and kidney function.2 Trajenta® has the lowest kidney excretion rate of all DPP-4 inhibitors.6-9
About our cardiovascular outcome trials
Cardiovascular outcome trials are highly relevant, as cardiovascular disease is a major complication and the leading cause of death in type 2 diabetes. Worldwide, most people with type 2 diabetes die of a cardiovascular event.10 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, which reduced the relative risk of cardiovascular death by 38 percent in adults with type 2 diabetes and established cardiovascular disease, on top of standard of care.†‡11-13 As a result, empagliflozin was the first oral type 2 diabetes medicine to have either a cardiovascular indication or data on the reduction of the risk of cardiovascular death included in the label in many countries.11,12
CAROLINA® is one of two cardiovascular outcome trials with the DPP-4 inhibitor, linagliptin.3,4 CAROLINA® and the CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk trial (CARMELINA®)14,15 provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor.
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.14,15 CARMELINA® 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.14,15 The trial met its primary endpoint,§ with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.14 CARMELINA® also included a key secondary composite endpoint,** showing a similar kidney safety profile compared to placebo.14 The overall safety profile of linagliptin in CARMELINA® was consistent with previous data and no new safety signals were observed.2,14 CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.14
To learn more about CAROLINA® and CARMELINA®, please visit: https://www.carmelinatrial.com/
Please click on the following link for ‘Notes to Editors’ and ‘References’:
* Secondary composite efficacy outcome defined as HbA1c at or
below 7 percent at the final visit without rescue medication, moderate
or severe hypoglycaemia or a 2 percent or greater weight gain.
† Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of MI or stroke
‡ Standard of care included cardiovascular medications and blood sugar lowering agents given at the discretion of physicians
§ Primary endpoint defined as time to first occurrence of the 3P-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
Media & PR
Phone: +49 (6132) 77 184867
Global Business Communications
Phone: +1 317 903 5640
About 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.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IFF to Present at Barclays Global Consumer Staples Conference September 520.8.2019 20:15:00 CEST | Press release
Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Barclays Global Consumer Staples Conference in Boston, Massachusetts, on Thursday, Sept 5, 2019 at 2:15 PM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/ho
Bermuda Tech Week 2019 to Celebrate Innovation and Explore Opportunities for Growth20.8.2019 14:27:00 CEST | Press release
Registration is under way and filling fast for Bermuda Tech Week 2019 which will take place at the Hamilton Princess & Beach Club from October 14-18, 2019. The programme of insightful and engaging events will explore future opportunities and challenges presented by emerging technologies such as artificial intelligence, blockchain, digital assets, insurtech and virtual reality. It will showcase Bermuda’s ongoing success in creating a welcoming, stable and well-regulated environment where technology and start-up companies can thrive. “Bermuda has a long history of innovation so we understand and recognise the power of technology to positively impact both the economy and society,” said Bermuda Premier David Burt. “Over the past two years, we have built on our strength as a global leader in regulating the risks associated with the global insurance industry to develop a clear regulatory framework around managing the risks associated with Fintech. Our progressive approach has drawn accolades
Limelight Networks Expands Developer Toolkit With New API and Portal Enhancements20.8.2019 14:25:00 CEST | Press release
Limelight Networks, Inc. (Nasdaq: LLNW), a leading provider of edge cloud services, today announced it has expanded the management and configuration capabilities of its suite of services with new Application Programming Interfaces (APIs) and web portal offerings. With these new capabilities in addition to existing APIs and Software Development Kits, developers now have more power to manage and monitor services across Limelight’s edge cloud platform. According to an IDC surveyi, more than half the organizations surveyed have already adopted DevOps practices, with an additional 20 percent planning to do so in the next 12 months. To help organizations meet these demands, Limelight has introduced expanded API capabilities to provide developers with access to the full set of configuration options available across its content delivery services. Limelight’s new Configuration API enables developers to configure Limelight services and programmatically integrate them into their workflows. It exp
Andersen Global Enters Zimbabwe20.8.2019 13:30:00 CEST | Press release
Andersen Global announced it has signed a collaboration agreement with Chimwamurombe Legal Practice (Zenas) in Zimbabwe. Andersen Global has built a presence in over 14 African countries in just under two years. Zenas was founded in 2015 and now has a team of 11 professionals who provide legal services to individuals, organizations, institutions and corporations. With a specialty of serving small to medium enterprises, they offer solutions in mining and construction, commercial, debt recovery, property law, labor law, family law, tax, technology, telecommunications, media and intellectual property law, and criminal litigation. “When we started, we set out to be the most sought-after, trusted legal firm in Zimbabwe,” said Fungai Chimwamurombe, Zenas Office Managing Director. “These values line up very closely with those firms in the Andersen Global international organization. We are happy to join a team of professionals that is equally committed to treating clients like family and deliv
DXC Technology and Google Cloud Announce Global Partnership to Drive Innovation for Enterprises at Scale20.8.2019 13:00:00 CEST | Press release
DXC Technology (NYSE: DXC) today announced a strategic partnership with Google Cloud that will enable enterprise clients to modernize their mission-critical IT and integrate digital solutions on Google Cloud Platform. With the strategic partnership, DXC is also launching a Google Cloud Platform Center of Excellence (COE) and a Google Cloud Artificial Intelligence (AI) COE to provide clients in key industries with secure, scalable and agile cloud-based digital platforms that leverage advanced data analytics capabilities. The new collaboration will initially focus on joint solutions in industries such as insurance, oil and gas exploration, automotive, consumer products, retail, and banking and capital markets. Google Cloud now joins the DXC Partner Network as a strategic partner. “Our new Google Cloud partnership will benefit clients looking to go to the next level in their digital transformation,” said Edward Ho, executive vice president and general manager, Offerings, DXC. “Google Clou
AnitaB.org Welcomes New Executives to Achieve Ambitious Goal of 50/50 Tech Equity by 202520.8.2019 13:00:00 CEST | Press release
Today, global nonprofit AnitaB.org announced that with its recent new hires it has fully staffed its Executive Team working on the ambitious goal of 50/50 intersectional tech equity by 2025. Three new hires join its executive bench to help achieve the company’s mission: Kety Maria Esquivel as Vice President of Marketing and Communications; Robert G. Read as Vice President, Business Development and Partnership Success; and Victoria Hughes as Vice President of People and Culture. The three new appointees will join CEO and President Brenda Darden Wilkerson’s leadership team as the non-profit tech women’s organization looks to expand its global reach and continues to improve its roster of AnitaB.org/365 programs that help women and underrepresented communities gain access and career opportunity through technology. Esquivel has been brought in to lead the world-wide marketing team, bringing more than two decades of global marketing and communications experience to the role. Prior to AnitaB.