TRAJENTA®: Ongoing studies.

Cardiovascular outcome trials.

The ongoing CAROLINA® study is the only DPP4i cardiovascular outcome trial with an active comparator (glimepiride).1-3

  • Primary endpoint

    Composite of Major Cardiovascular Events1

CV: Cardiovascular; IC: informed consent.
Moderate-to-high risk of CV events defined as: Previous vascular disease OR evidence of vascular-related end-organ damage OR age ≥70 years OR at least two of the following risk factors: i) T2D duration >10 years (ii) Systolic BP >140 mmHg (or on at least 1 BP-lowering treatment) <6 months prior to IC (iii) Current daily cigarette smoking (iv) LDL-cholesterol ≥135 mg/dL (3.5 mmol/L)(or specific current treatment for this lipid abnormality) <6 months prior to IC.

The ongoing CARMELINA® study is the only DPP4i cardiovascular outcome trial that will also test for renal outcomes.1

  • Primary endpoint

    Time to first occurrence of any of the following components:
    CV death, non-fatal MI, non-fatal stroke (3P-MACE)

  • Key secondary endpoint

    Time to first occurrence of the any of the following components:
    Renal death, sustained ESRD or a sustained decrease of ≥40% in eGFR

KD: Chronic kidney disease; CV: Cardiovascular; eGFR: Estimated glomerular filtration rate; ESRD: End stage renal disease; MACE: Major adverse cardiac event; MI: Myocardial infarction.

*High vascular risk is defined as
1) albuminuria (micro or macro) and previous macrovascular disease and/or
2) impaired renal function with predefined UACR.