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 for Tradjenta (linagliptin) versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).
CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. The trial evaluated the cardiovascular safety of Tradjenta (5 mg once daily) compared with the sulfonylurea glimepiride, on top of standard of care, in 6,033 adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease. The study assessed Tradjenta 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. The overall safety profile of Tradjenta in CAROLINA was consistent with previous data, and no new safety signals were observed.
People with type 2 diabetes have an increased risk of cardiovascular disease, and despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for this population. Together with CARMELINA, which demonstrated similar long-term cardiovascular safety compared with placebo in adults with type 2 diabetes at high risk for cardiovascular and/or kidney disease, CAROLINA confirms the long-term overall safety profile of Tradjenta in a broad range of adults with type 2 diabetes.
“Guidelines from the American College of Cardiology and American Diabetes Association recommend type 2 diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease,” said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “But physicians considering additional therapies to lower glucose values for their patients need a DPP-4 inhibitor with an established long-term safety profile. Along with CARMELINA, CAROLINA provides Tradjenta with one of the most comprehensive datasets on the safety of a DPP-4.”
“These data provide further confidence in the well-established safety and tolerability profile of Tradjenta for the treatment of adults with type 2 diabetes,” added Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “Tradjenta 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 June 10 at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.
Source: Company Press Release