Boehringer Ingelheimer and Lilly announced on 7/19/18 that 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 Trajenta® (linagliptin) demonstrating similar cardiovascular safety compared to placebo. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today positive top-line results, which evaluated the impact of treatment with linagliptin vs. 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 linagliptin in CARMELINA, including adults with kidney disease, was consistent with previous data and no new safety signal was observed.
People who have diabetes are at an increased risk of 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.
“Linagliptin demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “CARMELINA provides confidence in linagliptin as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes.”
The full results of CARMELINA will be presented on 4 October at the 54th European Association for the Study of Diabetes Annual Meeting in Berlin, Germany.
Trajenta is a one dose, once daily DPP-4-inihibitor that provides significant efficacy in the reduction of blood sugar levels for adults with type 2 diabetes. It can be prescribed for people with type 2 diabetes regardless of age, disease duration, ethnicity, body mass index (BMI), liver and kidney function. Trajenta has the lowest kidney excretion rate of all DPP-4 inhibitors. It is prescribed at the same dose and has demonstrated proven efficacy regardless of kidney function, making it simple to administer and use.