The CARMELINA® study is a multi-national, randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries (ClinicalTrials.gov identifier: NCT01897532) (Fig. 2 ). CARMELINA® is an event-driven trial designed to assess the impact of linagliptin versus placebo on CV and kidney outcomes in a population of patients with T2D enriched for both macrovascular and kidney microvascular risk. The study is designed to run until at least 611 participants have had an adjudicated primary-outcome event. The study protocol was approved by institutional review boards, independent ethics committees and competent authorities according to national and international regulations. CARMELINA® was conducted in accordance with the ICH Harmonised Tripartite Guideline for Good Clinical Practice. All participants provided written informed consent prior to entering the study.![]()
Design of the CARMELINA® trial. *Additional glucose-lowering therapy may be given on top of study medication if HbA1c > 7.5%; investigators are encouraged to treat all other CV risk factors in accordance with local or regional standards of care. †Participants who stop study drug early are observed until study end (not just until 30 days after the end of treatment with study drug). CV cardiovascular, HbA1c glycated hemoglobin A1c
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