DPP-4 inhibitor effective and safe in T2DM
The CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk (CARMELINA) study met its primary endpoint, and demonstrated similar cardiovascular (CV) safety outcomes after treatment with the DPP-4 inhibitor linagliptin in T2DM patients, compared to placebo.
The CARMELINA study was a randomized, double-blind, placebo-controlled clinical trial, evaluating the long-term effect of linagliptin on CV safety in 6,979 adult T2DM patients at high CV risk, the majority of whom also had kidney disease, for a duration of 2.2 years.
The primary outcome of the study consisted of time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE) after treatment with either 5 mg once daily linagliptin or placebo, both added on top of standard care (glucose-lowering drugs and CV drugs, including antihypertensive and lipid-lowering agents). 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.
The DPP-4 inhibitor linagliptin, prescribed as one dose, significantly reduces blood glucose levels in T2DM adults and can be prescribed for individuals with T2DM, regardless of age, disease duration, ethnicity, BMI, and liver and kidney function and has demonstrated proven efficacy regardless of kidney function.
Results of the CARMELINA study will be presented on 4 October at 54th European Association for the study of Diabetes Annual Meeting in Berlin, Germany.