Watch the EASD 2018 data disclosure session
CARMELINA: official trial data disclosure by members of the trial steering committee
CARMELINA subgroup analysis:
Why do we need the CARMELINA trial?
CARMELINA was a multinational, randomised, double-blind, placebo-controlled CVOT7
CARMELINA was specifically designed to evaluate the CV (3P-MACE) and kidney safety profile of linagliptin7
CARMELINA studied a patient population that is relevant to clinical practice7
CARMELINA demonstrated data for the long-term CV and kidney safety profile of linagliptin
Cardiovascular
Hospitalisation for
heart failure
Kidney
Overall safety
What is the meaning of the CARMELINA results?7, 8
Want to know more about the CARMELINA trial? Click here for further resources
For information on the CAROLINA trial, please click here
A robust CVOT programme assessing the long-term
CV
and kidney safety profile of linagliptin
Patients eligible for enrolment in CARMELINA were adults with T2D, HbA1c values of 6.5–10.0% and high CV
and
renal risk†
*Linagliptin patients aged 65 to <75 years only; †Established kidney disease was defined in CARMELINA as eGFR of 15–<45 ml/min/1.73 m2 or eGFR ≥45–75 ml/min/1.73 m2 with UACR >200 mg/g or equivalent;7 proportion of patients with established kidney disease was not reported in the elderly subgroup analysis. High CV risk was defined as a history of coronary artery disease, stroke or peripheral vascular disease, and microalbuminuria or macroalbuminuria, defined as UACR >30 mg/g or equivalent;7 ‡Time to first occurrence of CV death, non-fatal MI or non-fatal stroke; §Because the tests for superiority of the primary outcome (3P-MACE) and the key secondary outcome (composite kidney outcome) in the overall population were not met (p=0.74 and p=0.62 for superiority, respectively), all other analyses and outcomes are considered exploratory;7 ¶Time to first occurrence of sustained eGFR decrease by ≥40%, progression to sustained ESKD or death due to kidney disease7
3P-MACE, 3-point major adverse cardiovascular events; CV, cardiovascular; CVOT, cardiovascular outcomes trial; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; HbA1c, glycated haemoglobin; MI, myocardial infarction; T2D, type 2 diabetes; UACR, urine albumin-to-creatinine ratio
1. Diabetes Canada Clinical Practice Guidelines Expert Committee. Can J Diabetes 2018;42:S162; 2. American Diabetes Association. Diabetes Care 2020;43:S1; 3. Buse JB et al. Diabetes Care 2020;43:487; 4. Sarwar N et al. Lancet 2010;375:2215; 5. Thomas M et al. Nat Rev Nephrol 2016;12:73; 6. Diabetes Canada. Can J Diabetes 2018;42:S201; 7. Rosenstock J et al. JAMA 2019;321:69; 8. Cooper M et al. Diabetes Obes Metab 2020;22:1062
*Linagliptin patients aged 65 to <75 years only; †Established kidney disease was defined in CARMELINA as eGFR of 15–<45 ml/min/1.73 m2 or eGFR ≥45–75 ml/min/1.73 m2 with UACR >200 mg/g or equivalent;7 proportion of patients with established kidney disease was not reported in the elderly subgroup analysis. High CV risk was defined as a history of coronary artery disease, stroke or peripheral vascular disease, and microalbuminuria or macroalbuminuria, defined as UACR >30 mg/g or equivalent;7 ‡Time to first occurrence of CV death, non-fatal MI or non-fatal stroke; §Because the tests for superiority of the primary outcome (3P-MACE) and the key secondary outcome (composite kidney outcome) in the overall population were not met (p=0.74 and p=0.62 for superiority, respectively), all other analyses and outcomes are considered exploratory;7 ¶Time to first occurrence of sustained eGFR decrease by ≥40%, progression to sustained ESKD or death due to kidney disease7
3P-MACE, 3-point major adverse cardiovascular events; CV, cardiovascular; CVOT, cardiovascular outcomes trial; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; HbA1c, glycated haemoglobin; MI, myocardial infarction; T2D, type 2 diabetes; UACR, urine albumin-to-creatinine ratio
1. Diabetes Canada Clinical Practice Guidelines Expert Committee. Can J Diabetes 2018;42:S162; 2. American Diabetes Association. Diabetes Care 2020;43:S1; 3. Buse JB et al. Diabetes Care 2020;43:487; 4. Sarwar N et al. Lancet 2010;375:2215; 5. Thomas M et al. Nat Rev Nephrol 2016;12:73; 6. Diabetes Canada. Can J Diabetes 2018;42:S201; 7. Rosenstock J et al. JAMA 2019;321:69; 8. Cooper M et al. Diabetes Obes Metab 2020;22:1062