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

CARMELINA®:
a unique trial investigating the long-term CV and kidney safety profile of linagliptin versus placebo

Why do we need the CARMELINA® trial?

In patients with T2D and ASCVD, many societies now recommend that the initial choice of glucose-lowering therapy following metformin should be based on evidence of proven CV benefit1–4

When other glucose-lowering medications are needed DPP-4 inhibitors represent a common add-on treatment choice

The CARMELINA® (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) CVOT investigated the long-term CV and kidney safety profile of linagliptin versus placebo, on top of standard of care5

CARMELINA® was a multinational, randomised, double-blind, placebo-controlled CVOT5

Study medication was given on top of stable background glucose-lowering therapy and patients were treated for CV risk factors in accordance with local guidelines

CARMELINA® was specifically designed to evaluate the CV (3P-MACE) and kidney safety profile of linagliptin5

The CV safety profile of linagliptin was assessed using 3P-MACE (CV death, non-fatal MI, non-fatal stroke)

CARMELINA® is the first CVOT to specifically assess the kidney safety profile of a DPP-4 inhibitor

CARMELINA® studied a patient population that is relevant to clinical practice5

CARMELINA® was designed to recruit patients with T2D, including those with CV and/or kidney disease: a population that has previously been underrepresented in other CVOTs in diabetes

The characteristics of patients enrolled in CARMELINA® are representative of those seen in clinical practice...

...and the trial included patients across a broad range of kidney function and had the highest proportion of patients with reduced kidney function compared with other DPP-4 inhibitor CVOTs to date

CARMELINA® confirmed the long-term CV and kidney safety profile of linagliptin5

Cardiovascular

Long-term CV safety profile confirmed

The 3P-MACE* primary outcome occurred in 434/3494 (12.4%) and 420/3485 (12.1%) patients in the linagliptin and placebo groups, respectively

HR 1.02 (95% CI 0.89, 1.17)

p<0.001 for non-inferiority

Hospitalisation for heart failure

No increased risk of hospitalisation for heart failure

Rates of hospitalisation for heart failure did not differ between treatment groups: 209/3494 (6.0%) and 226/3485 (6.5%) in the linagliptin and placebo groups, respectively

HR 0.90 (95% CI 0.74, 1.08)

p=0.26

Kidney

Long-term kidney safety profile confirmed

The key kidney outcome occurred in 327/3494 (9.4%) and 306/3485 (8.8%) patients in the linagliptin and placebo groups, respectively

HR 1.04 (95% CI 0.89, 1.22)

p=0.62

Overall safety

CARMELINA® confirmed the overall safety profile of linagliptin

What is the meaning of the CARMELINA® results?5

In CARMELINA®, linagliptin demonstrated a long-term CV safety profile in patients with T2D, including those with CV and/or kidney disease

Linagliptin showed no increase in risk of hospitalisation for heart failure, even in patients at high risk of heart failure

Linagliptin demonstrated a reassuring long-term kidney safety profile, with a reduction in progression of albuminuria

CARMELINA® thus provides unique clinical evidence for a patient population that is highly relevant to clinical practice

Want to know more about the CARMELINA® trial? Click here for further resources

For information on the CAROLINA® trial, please click here

Logo Carmelina
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A robust CVOT programme assessing the long-term CV and kidney safety profile of linagliptin
*Time to first occurrence of CV death, non-fatal MI or non-fatal stroke; Time to first occurrence of sustained eGFR decrease by ≥40%, progression to sustained ESKD or death due to kidney disease
3P-MACE, 3-point major adverse cardiovascular events; ASCVD, atherosclerotic cardiovascular disease; CV, cardiovascular; CVOT, cardiovascular outcomes trial; DPP-4, dipeptidyl peptidase-4; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; MI, myocardial infarction; T2D, type 2 diabetes
1. Diabetes Canada Clinical Practice Guidelines Expert Committee. Can J Diabetes 2018;42:S162; 2. American Diabetes Association. Diabetes Care 2019;42:S1; 3. Davies MJ et al. Diabetes Care 2018;41:2669; 4. Das SR et al. J Am Coll Cardiol 2018;72:3200; 5. Rosenstock J et al. JAMA 2019;321:69

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