CAROLINA Tradjenta trial hits primary CV outcomes target

Results from the 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 (Sanofi’s Amaryl) in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).

Conducted by German family-owned Boehringer Ingelheim and US pharma major Eli Lilly (NYSE: LLY), 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.

"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 Dr Thomas Seck, senior vice president, medicine and regulatory affairs, at Boehringer Ingelheim Pharmaceuticals, adding: "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."