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Boehringer Ingelheim and Lilly’s CAROLINA® cardiovascular outcome trial for Trajenta® meets primary endpoint of non-inferiority compared to glimepiride

Trajenta® demonstrates no increased cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk
With a median follow-up of more than 6 years, CAROLINA® adds evidence to the long-term safety profile of Trajenta® in a broad range of adults with type 2 diabetes

News provided by Boehringer Ingelheim International GmbH
February 19, 2019 16:50 KST

INGELHEIM, GERMANY & INDIANAPOLIS--(Business Wire / Korea Newswire) February 19, 2019 -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority of Trajenta® (linagliptin) vs glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).[1,2]

CAROLINA® is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor.[1,2] The trial evaluated the cardiovascular safety of linagliptin (5 mg once daily) compared to the sulphonylurea glimepiride, on top of standard of care in 6,033 adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease.[1,2] The trial 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.[1,2] The overall safety profile of linagliptin in CAROLINA® was consistent with previous data and no new safety signals were observed.[3]

People who have type 2 diabetes are at an increased risk of cardiovascular disease and, despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for this population.[4] Together with CARMELINA®, the placebo-controlled cardiovascular outcome trial, which demonstrated long-term cardiovascular safety in adults with type 2 diabetes at high risk for heart and kidney disease,[5] CAROLINA® confirms linagliptin’s long-term overall safety profile in a broad range of adults with type 2 diabetes.

“Many guidelines recommend early use of a diabetes treatment with cardiovascular benefit,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim. “When other therapies such as DPP-4 inhibitors are considered for people with type 2 diabetes, physicians need a treatment with an established long-term safety profile. With these results, CAROLINA® expands our understanding of the long-term cardiovascular safety of linagliptin, which now has one of the most comprehensive datasets on the cardiovascular safety of a DPP-4 inhibitor.”

“These data provide further confidence in the well-established safety and tolerability profile of linagliptin for the treatment of adults with type 2 diabetes,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “Linagliptin is an important option for physicians considering a DPP-4 inhibitor for their patients with type 2 diabetes. Boehringer Ingelheim and Lilly look forward to sharing the full results later this year.”

The full results of CAROLINA® will be presented on 10 June at the American Diabetes Association’s 79th Scientific Sessions in San Francisco, United States.

About CAROLINA®

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.[1,2] 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).[2] 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.[1,2] These people reflect patients that doctors typically see in their daily clinical practice.[6]

CAROLINA® was led by an academic trial steering committee and Boehringer Ingelheim and Eli Lilly and Company. CAROLINA® is the first DPP-4 inhibitor, active-comparator cardiovascular outcome trial.

About Trajenta® (linagliptin)

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.[3] Trajenta® has the lowest kidney excretion rate of all DPP-4 inhibitors.[7,8,9,10]
 
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.[4] 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.[11,12,13,14,15] 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.[1,2] CAROLINA® and the CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk trial (CARMELINA®)[5,16] 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.[5,14] 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.[5,14] The trial met its primary endpoint,[17] with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.[5] CARMELINA® also included a key secondary composite endpoint,[18] showing a similar kidney safety profile compared to placebo.[5] The overall safety profile of linagliptin in CARMELINA® was consistent with previous data and no new safety signals were observed.[3,5] CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.[5]

To learn more about CARMELINA®, please visit: https://www.carmelinatrial.com/

Please click on the following link for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/press-release/CAROLINA-top-line

Contact

Boehringer Ingelheim
Tetsu Owari
Media & PR
+49 (6132) 77 184867
press@boehringer-ingelheim.com

Lilly Diabetes
Stephan Thalen
Global Business Communications
+1 317 903 5640
stephan.thalen@lilly.com

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