The primary endpoint of the trial was defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE).
Tradjenta had shown similar cardiovascular safety compared with placebo on cardiovascular safety on top of standard of care during the trial held in patients with type 2 diabetes at high cardiovascular risk, said the companies.
Standard of care included glucose lowering agents and cardiovascular drugs such as antihypertensive and lipid lowering agents.
Most of the patients enrolled in the CARMELINA trial also had kidney disease, which is a key risk factor for cardiovascular disease. Tradjenta’s overall safety profile in the trial, including adults with kidney disease, was on par with previous data with no new safety signals observed.
Boehringer Ingelheim Pharmaceuticals medicine and regulatory affairs senior vice president Thomas Seck said: “About half of patients with type 2 diabetes worldwide also have chronic kidney disease, and the majority of deaths among people with kidney disease occur as a result of cardiovascular complications.
“These CARMELINA data add important information regarding the long-term clinical safety of Tradjenta in a patient population that is particularly vulnerable to poor cardiovascular outcomes.”
The multi-national, randomized, double-blind, placebo-controlled clinical trial enrolled 6,979 adults with type 2 diabetes from 27 countries. It was held at more than 600 sites observed for a median duration of 2.2 years.
Lilly Diabetes product development vice president Jeff Emmick said: “Tradjenta demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function.
“CARMELINA provides confidence in Tradjenta as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes.”
Tradjenta was approved in the US in 2011 to lower blood sugar in adults with type 2 diabetes. The drug can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes such as metformin, sulfonylurea or pioglitazone.