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CARMELINA®: official trial data disclosure by members of the trial steering committee

CARMELINA®:
evaluating the impact of linagliptin versus placebo on CV and kidney safety

Background and purpose

CARMELINA® is a long-term cardiovascular outcomes trial (CVOT) testing the impact of treatment with linagliptin versus placebo, on top of standard of care, on cardiovascular (CV) as well as kidney safety.

CARMELINA® will help to support informed treatment decision-making in patients with type 2 diabetes (T2D) and established CV and/or kidney complications.

Trial design

CARMELINA® is a multinational, randomised, double-blind, placebo-controlled clinical trial being conducted in 27 countries. Patients with T2D were randomised to daily oral treatment with linagliptin or placebo on top of standard of care.

CV, cardiovascular
Rosenstock J et al. Cardiovasc Diabetol 2018;17:39

Trial endpoints

CARMELINA® is a unique trial specifically designed to evaluate both CV and kidney safety.

CV, cardiovascular; eGFR, estimated glomerular filtration rate; MI, myocardial infarction
Rosenstock J et al. Cardiovasc Diabetol 2018;17:39

Trial population

CARMELINA® was designed to recruit patients with T2D and established CV and/or kidney complications.

*Also defined as ≥30 μg/min or ≥30 mg/24 h
BMI, body mass index; CV, cardiovascular; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycated haemoglobin; MI, myocardial infarction; SGLT2, sodium-glucose co-transporter-2; TIA, transient ischaemic attack; UACR, urine albumin-to-creatinine ratio
Rosenstock J et al. Cardiovasc Diabetol 2018;17:39

CARMELINA® includes a unique population of patients with CV disease and/or kidney disease.

CKD, chronic kidney disease; CV, cardiovascular
Rosenstock J et al. Cardiovasc Diabetol 2018;17:39

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