CARMELINA trial reports on CV safety of Tradjenta in diabetes type 2 patients with CV risk.- Boehringer + Eli Lilly.

CARMELINA (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 Tradjenta demonstrating similar cardiovascular safety compared with placebo.

Boehringer Ingelheim and Eli Lilly announced the positive top-line results from the trial, which evaluated the impact of treatment with Tradjenta compared with placebo on cardiovascular safety on top of standard of care. The study included 6,979 adults with type 2 diabetes and high cardiovascular risk. The majority of patients also had kidney disease, an important risk factor for cardiovascular disease. The overall safety profile of Tradjenta in CARMELINA, including adults with kidney disease, was consistent with previous data, and no new safety signals were observed. People who have diabetes are at an increased risk of both cardiovascular disease and chronic kidney disease. Despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for people living with diabetes, and about two-thirds of chronic kidney disease cases are attributable to metabolic conditions, such as diabetes, obesity and hypertension. The full results of CARMELINA will be presented on 4 October 2018 at the 54th European Association for the Study of Diabetes Annual Meeting in Berlin.

CARMELINA is a multi-national, randomized, 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. The study was designed to assess the effect of Tradjenta (5 mg once daily) compared with placebo (both added to standard of care) on cardiovascular outcomes in adults with type 2 diabetes and high cardiovascular risk, the majority of whom also had kidney disease. As a secondary measure, the study also assessed the effect of Tradjenta compared with placebo on renal outcomes in adults with type 2 diabetes and high cardiovascular risk. This population reflects patients with type 2 diabetes that doctors see in their daily practice. 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).