Carmelina Cardiovascular Outcome Trial met its Primary Endpoint

Carmelina 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 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.

"Carmelina reinforces the long-term clinical safety profile of linagliptin in adults with type 2 diabetes, even in those most vulnerable for vascular complications," said Waheed Jamal, MD, Corporate Vice President and Head of Cardiometabolic Medicine, Boehringer Ingelheim. "The trial adds important new evidence for patients at high risk for heart and kidney disease, a population that has previously been underrepresented in other cardiovascular outcome trials in diabetes."

"Linagliptin demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function," said 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."

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