Boehringer Ingelheim and Lilly announce Trajenta®’s CARMELINA® cardiovascular outcome trial met its primary endpoint
19.7.2018 15:08:00 EEST | Business Wire | Press release
CARMELINA®1 (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) met its primary endpoint, defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE), with Trajenta® (linagliptin) demonstrating similar cardiovascular safety compared to placebo. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today positive top-line results, which evaluated the impact of treatment with linagliptin vs. placebo on cardiovascular safety on top of standard of care.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180719005409/en/
The study included 6,979 adults with type 2 diabetes and high cardiovascular risk.1 The majority of patients also had kidney disease, an important risk factor for cardiovascular disease. The overall safety profile of linagliptin in CARMELINA®, including adults with kidney disease, was consistent with previous data and no new safety signal was observed.
People who have diabetes are at an increased risk of cardiovascular disease and chronic kidney disease.2,3 Despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for people living with diabetes,4 and about two thirds of chronic kidney disease cases are attributable to metabolic conditions, such as diabetes, obesity and hypertension.5,6,7
“CARMELINA® reinforces the long-term clinical safety profile of linagliptin in adults with type 2 diabetes, even in those most vulnerable for vascular complications,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiometabolic Medicine, Boehringer Ingelheim. “The trial adds important new evidence for patients at high risk for heart and kidney disease, a population that has previously been underrepresented in other cardiovascular outcome trials in diabetes.”
“Linagliptin demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “CARMELINA® provides confidence in linagliptin as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes.”
The full results of CARMELINA® will be presented on 4 October at the 54th European Association for the Study of Diabetes Annual Meeting in Berlin, Germany.
About the Study
CARMELINA® (CArdiovascular safety
and Renal Microvascular outcomE with LINAgliptin in patients with type 2
diabetes at high vascular risk) 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.1 The study was
designed to assess the effect of Trajenta® (linagliptin) (5
mg once daily) compared to placebo (both added to standard of care) on
cardiovascular outcome in adults with type 2 diabetes and cardiovascular
risk, the majority of whom also had kidney disease. This population
reflects patients that doctors see in their daily practice. 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.*
Standard of care included both glucose lowering agents and cardiovascular drugs (including antihypertensive and lipid lowering agents).
About Trajenta
®
(linagliptin)
Trajenta®
is a one dose, once daily DPP-4-inihibitor that provides significant
efficacy in the reduction of blood sugar levels for adults with type 2
diabetes. It can be prescribed for people with type 2 diabetes
regardless of age, disease duration, ethnicity, body mass index (BMI),
liver and kidney function.8 Trajenta® has the
lowest kidney excretion rate of all DPP-4 inhibitors.8,9,10,11,12
It is prescribed at the same dose and has demonstrated proven efficacy
regardless of kidney function,8,13,14 making it simple to
administer and use.
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.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,
which demonstrated a 38% relative risk reduction in cardiovascular death
in adults with type 2 diabetes and established cardiovascular
disease.†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 type 2 diabetes at increased cardiovascular risk, however, the majority did not yet have heart and kidney disease. The study is expected to complete in 2018. CARMELINA® and CAROLINA® will provide the most comprehensive clinical database on the long-term safety profile of a DPP-4-inhibitor in a broad range of adults with type 2 diabetes.
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/CARMELINA-high-level
* glomerular filtration rate below 30 mL/min/m2
† Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005409/en/
Contact information
Boehringer Ingelheim
Katharina Opitz
Product
Communication
Email: press@boehringer-ingelheim.com
Phone:
+49 (6132) 77 2012
or
Grant Smith
Manager, Global
Business Communications
Lilly Diabetes
Email: grant.smith@lilly.com
Phone:
+1 (317) 954 9907
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Enry’s Island Unveils “Enry’s Island Adventures”: Venture Capital Becomes a Videogame and Launches the “Strap” Movement on Kickstarter3.4.2026 10:47:00 EEST | Press release
Enry’s Island SpA (WBAG: EIOS), the world’s first publicly traded Venture Builder, today announced the upcoming Kickstarter launch of Enry’s Island Adventures (EIA), developed by its New York-based portfolio company, Enry’s Island Adventures LLC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402548535/en/ The game is designed to make venture capital accessible to new generations, transforming startup creation into an engaging and social gaming experience. After three years of R&D, EIA introduces a "bleisure" model (business + leisure): players learn to launch and manage startups through gameplay that includes real business KPIs, a customizable and evolving personal island, synchronous and asynchronous multiplayer modes, social events, and community-driven seasonal missions. The “VC revolution”: teaching and democratizing through play "I agree with Elon Musk that the best way to teach is through a video game, and this is
SES Announces Results of the Annual General Meeting2.4.2026 17:49:00 EEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 17:00:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those business outcomes; establish a structured runway to plan, test, and strategically time the deployment
Andersen Consulting Adds Multiplica2.4.2026 16:30:00 EEST | Press release
Andersen Consulting enters into a Collaboration Agreement with Multiplica, a digital consulting firm that helps organizations design, build, and scale impactful digital experiences. Founded in Spain with a presence in Latin America and the U.S., Multiplica focuses on user research and discovery, customer experience research, digital strategy, data modeling and analysis, report automation and data visualization, conversion rate optimization, product design, and user experience design. The firm helps organizations accelerate digital transformation by building digital capabilities, teams, and assets that advance expertise across digital products, consulting, and talent development. Multiplica enables clients to forecast emerging trends in digital experience and transform their businesses through enhanced digital channels and customer engagement. “Collaborating with Andersen Consulting represents an exciting opportunity to extend our reach and impact,” said David Boronat, CEO of Multiplica
Brightfin Unifies Brand Following Proven Optics Merger, Delivering a New Standard for Technology Cost Optimization2.4.2026 16:00:00 EEST | Press release
Brightfin today announced that, following its merger with Proven Optics, the combined company will operate under a single brand: Brightfin. The unified company brings together deep expertise in Technology Expense Management (TEM) and IT Financial Management (ITFM) to help organizations better understand, manage, and reduce total technology spend. Technology spending will exceed $6 Trillion this year, and for most organizations, it remains one of the least understood. CIOs can tell you what they’re spending. Far fewer can tell you whether it’s working. “Over the past several months, we’ve brought these two businesses together around a shared purpose: help enterprise businesses better understand and optimize their technology spend,” said Joel Martins, CEO of Brightfin. “What we are seeing now is a shift. Visibility alone isn’t enough. Teams need to be able to act, tied to real financial outcomes. See Clearly. Spend Better. That is our north star, and that is what our platform is built to
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom