CARMELINA: Linagliptin no effect on cognitive decline
Linagliptin has no impact on cognitive decline when given on top of standard of care in patients with type 2 diabetes mellitus (T2DM), a CARMELINA substudy has shown.
“While the primary objective of the placebo-controlled CARMELINA study was to examine the long-term cardiovascular [CV] safety of linagliptin in patients with T2DM and comorbid CV and/or kidney diseases, it also explored the effect of linagliptin on cognitive decline,” explained investigator Professor Geert Jan Biessels of the University Medical Center Utrecht, the Netherlands.
In this substudy, however, the incidence of accelerated cognitive decline was comparable between the linagliptin and placebo groups (28.4 percent vs 29.3 percent; risk ratio, 0.96; p=0.6938).
The substudy included 1,545 CARMELINA participants (linagliptin, n=800; placebo, n=745). The primary endpoint of incidence of accelerated cognitive decline was defined as Mini Mental State Examination (MMSE) and/or attention and executive functioning score ≤16th percentile of the regression-based index scores for cognitive decline in the total study population. Baseline and end-of-treatment cognitive assessments were conducted around 2.5 years apart.