CAROLINA®:
evaluating the long-term CV safety profile of linagliptin versus glimepiride in patients with early T2D at increased CV risk

Why do we need the CAROLINA® 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 benefit1-5

When other glucose-lowering medications are needed, DPP-4 inhibitors and sulphonylureas represent two common add-on treatment choices

In CARMELINA®, linagliptin demonstrated a long-term CV and kidney safety profile in patients with T2D including those with CV and/or kidney disease6

CAROLINA® uniquely assessed the long-term CV safety profile of linagliptin versus glimepiride in patients with early T2D at increased CV risk7,8

CAROLINA® was specifically designed to evaluate the long-term CV safety profile (3P-MACE) of linagliptin7,8

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

Topline announcement

CAROLINA® met its primary endpoint, defined as non-inferiority of linagliptin versus glimepiride in time to first occurrence of CV death, non-fatal MI or non-fatal stroke (3P-MACE)8

The overall safety profile of linagliptin in CAROLINA® was consistent with previous data, and no new safety signals were observed8

Together, CAROLINA® and CARMELINA® constitute a comprehensive CVOT programme that demonstrates linagliptin’s long-term CV and overall safety profile in a broad range of adults with T2D6,8

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

For information on the CARMELINA® trial, please click here

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A robust CVOT programme assessing the long-term CV and kidney safety profile of linagliptin

*To ensure an adequate level of glycaemic control for patients, investigators could institute glycaemic rescue medication, provided specific protocol criteria were met; Starting dose of 1 mg/day up-titrated to a potential maximum of 4 mg/day every 4 weeks for the first 16 weeks. Doses could be up- or down-titrated at any point of the study as required; Composite of 3P-MACE plus time to first occurrence of hospitalisation for unstable angina; §Between end of titration and final visit
3P-MACE, 3-point major adverse cardiovascular events; 4P-MACE, 4-point major adverse cardiovascular events; ASCVD, atherosclerotic cardiovascular disease; CV, cardiovascular; CVOT, cardiovascular outcomes trial; DPP-4, dipeptidyl peptidase-4; HbA1c, glycated haemoglobin; 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. Diabetes Canada Clinical Practice Guidelines Expert Committee. Can J Diabetes 2018;42:S201; 5. Das SR et al. J Am Coll Cardiol 2018;72:3200; 6. Rosenstock J et al. JAMA 2019;321:69; 7. Marx N et al. Diab Vasc Dis Res 2015;12:164; 8. Boehringer Ingelheim. Press release. 2019. http://www.boehringer-ingelheim.com/press-release/CAROLINA-top-line (accessed March 2019)

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