Boehringer Ingelheim and Eli Lilly have reported positive results from the CAROLINA cardiovascular outcomes trial of Tradjenta (linagliptin) in type 2 diabetes patients.
The trial met its primary endpoint of non-inferiority for Tradjenta over glimepiride in duration to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).
Tradjenta is a dipeptidyl peptidase-4 (DPP-4) inhibitor intended for use alongside a diet and exercise to lower blood sugar in adults with type 2 diabetes.
Type 2 diabetes patients are known to be at higher risk of cardiovascular disease, which remains the main cause of death for this population.
The multi-national, randomised, double-blind, active-controlled CAROLINA trial evaluated Tradjenta’s long-term impact, efficacy, and safety on cardiovascular morbidity and mortality.
It monitored 6,033 patients over a median time frame of six years at more than 600 sites in 43 countries and compared a once-daily 5mg dose of Tradjenta with sulfonylurea glimepiride.
The overall safety profile of Tradjenta was observed to be consistent with available data and no new signals were reported.
Lilly Diabetes Product Development vice-president Jeff Emmick said: “These data provide further confidence in the well-established safety and tolerability profile of Tradjenta for the treatment of adults with type 2 diabetes.
“Tradjenta is an important option for physicians considering a DPP-4 inhibitor for their patients with type 2 diabetes. Boehringer Ingelheim and Lilly look forward to sharing the full results later this year.”
Tradjenta was previously evaluated in another cardiovascular outcomes trial called CARMELINA.
This trial studied 6,979 type 2 diabetes patients for a median duration of 2.2 years at more than 600 sites in 27 countries.