Boehringer announces positive cardiovascular outcomes for linagliptin. Credit: © Boehringer Ingelheim.

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).

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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.

“Tradjenta is an important option for physicians considering a DPP-4 inhibitor for their patients with type 2 diabetes.”

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.

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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.