Boehringer Ingelheim and Lilly announce Trajenta®’s CARMELINA® cardiovascular outcome trial met its primary endpoint

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.

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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 54^th 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

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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