CARMELINA® CV Outcome Trial Result
TRADJENTA was evaluated for CV safety in a 2-year long CARMELINA® CV Outcome Trial1
Proportion of adult patients studied:
- Elderly* (57%)
- Established CV disease† (57%)
- Prevalent kidney disease‡ (74%)
- Established CV and prevalent kidney disease (33%)
Primary composite outcome was defined as the time to first occurrence of 3P-MACE:
- CV death
- Nonfatal MI
- Nonfatal stroke
TRADJENTA is not indicated for reduction in 3P-MACE.
TRADJENTA demonstrated CV safety with noninferiority to placebo for 3P-MACE
Primary endpoint: Time to 3P-MACE
(HR=1.02 [95% CI: 0.89-1.17]; P<.0.001 for noninferiority)
CARMELINA® Adverse Events
Adverse events occurred in 2697 (77.2%) and 2723 (78.1%) patients in the linagliptin and placebo groups; 1036 (29.7%) and 1024 (29.4%) had 1 or more episodes of hypoglycemia; and there were 9 (0.3%) vs 5 (0.1%) events of adjudication-confirmed acute pancreatitis.
CARMELINA® Trial Design
Randomized, double-blind, placebo-controlled, multicenter, noninferiority trial conducted at 605 clinical sites in 27 countries comparing the use of TRADJENTA administered once daily and placebo with usual care in patients with type 2 diabetes at high risk of CV and/or kidney events. A total of 6979 patients received TRADJENTA 5 mg (N=3494) or placebo (N=3485) and were followed for a median of 2.2 years. The primary endpoint was the reduction in risk of 3P-MACE, defined by the composite of CV death, nonfatal myocardial infarction, or nonfatal stroke.1
*Elderly was defined as patients ≥65 years of age.1
†Defined as albuminuria (UACR ≥30 mg/g creatinine or ≥30 μg albumin/min or ≥30 mg albumin/24 h) and previous macrovascular disease (≥1 of the following: confirmed history of myocardial infarction; advanced coronary artery disease; high-risk single-vessel coronary artery disease; history of ischemic or hemorrhagic stroke; presence of carotid artery disease; presence of peripheral artery disease).1
‡Defined as eGFR <60 mL/min/1.73 m2 and/or UACR >300 mg/g creatinine.1