mortality in patients with T2DM. Renal function decline is associated with increased risk of hospitalization and mortality.

Patients with T2DM and kidney disease are relatively under-represented population in CVOTs to date.

CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes mellitus at high vascular risk) is a long-term CVOT that is testing the impact of treatment with linagliptin vs. placebo, on top of standard of care, on CV outcomes and renal outcomes. This is a unique trial that will address important clinical questions.

CARMELINA includes the highest proportion of patients with established CKD compared with other DPP-4 inhibitor CVOTs. It will add evidence to the long-term clinical safety profile of linagliptin by including patients at advanced stages of kidney disease. It is the only DPP-4 inhibitor CVOT that will also test for renal outcomes.