– Study supports long-term cardiovascular safety of Tradjenta® (linagliptin) in adults with type 2 diabetes
RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I July 19, 2018 I CARMELINA® (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 Tradjenta® demonstrating similar cardiovascular safety compared with placebo. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced the positive top-line results from the trial, which evaluated the impact of treatment with Tradjenta compared with placebo on cardiovascular safety on top of standard of care.
People who have diabetes are at an increased risk of both cardiovascular disease and chronic kidney disease. Despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for people living with diabetes, and about two-thirds of chronic kidney disease cases are attributable to metabolic conditions, such as diabetes, obesity and hypertension.
“About half of patients with type 2 diabetes worldwide also have chronic kidney disease, and the majority of deaths among people with kidney disease occur as a result of cardiovascular complications,” said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These CARMELINA data add important information regarding the long-term clinical safety of Tradjenta in a patient population that is particularly vulnerable to poor cardiovascular outcomes.”
“Tradjenta 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, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “CARMELINA provides confidence in Tradjenta 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 Oct. 4 at the 54th European Association for the Study of Diabetes Annual Meeting in Berlin.
About the Study (NCT01897532)
CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) is a multi-national, randomized, 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. The study was designed to assess the effect of Tradjenta (5 mg once daily) compared with 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. As a secondary measure, the study also assessed the effect of Tradjenta compared with placebo on renal outcomes in adults with type 2 diabetes and high cardiovascular risk. This population reflects patients with type 2 diabetes 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 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. 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 percent relative risk reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.††
CARMELINA is one of two cardiovascular outcome trials with the DPP-4 inhibitor Tradjenta. CAROLINA®, will be the first DPP-4 inhibitor cardiovascular outcome trial to compare commonly used second line treatments — Tradjenta and the sulfonylurea 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.
What is TRADJENTA?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.
About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives.
In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
SOURCE: Eli Lilly
