Trajenta demonstrates no increased cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk
INGELHEIM, Germany & INDIANAPOLIS -- (BUSINESS WIRE) -- 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 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190214005409/en/ 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® 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)
About our cardiovascular outcome trials 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 ore about CARMELINA®, please visit: https://www.carmelinatrial.com/
Please click on the following link for ‘Notes to Editors’ and ‘References’: View source version on businesswire.com: https://www.businesswire.com/news/home/20190214005409/en/ CONTACT:
Tetsu Owari
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