Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study

• DOI: 10.1007/s00125-021-05393-8
• Publication Date: 2021-02-10T02:40:40Z
• Authors: Geert Jan Biessels; Chloë Verhagen; Jolien Janssen; Esther van den Berg; Gudrun Wallenstein; Bernard Zinman; Mark A. Espeland; Odd Erik Johansen
• Keywords: Linagliptin; Glimepiride; Albuminuria; Cognitive Decline

Abstract Aims/hypothesis Type 2 diabetes, particularly with concomitant CVD, is associated an increased risk of cognitive impairment. We assessed the effect on accelerated decline (ACD) DPP-4 inhibitor linagliptin vs sulfonylurea glimepiride in individuals type diabetes. Methods The CAROLINA-COGNITION study was part randomised, double-blind, active-controlled CAROLINA trial that evaluated cardiovascular safety age ≥40 and ≤85 years HbA 1c 48–69 mmol/mol (6.5–8.5%) receiving standard care, excluding insulin therapy. Participants were randomised 1:1 using interactive telephone- web-based system treatment assignment determined by a computer-generated random sequence stratification center. primary outcome occurrence ACD at end follow-up, defined as regression-based index score ≤16th percentile either Mini-Mental State Examination (MMSE) or composite measure attention executive functioning, participants baseline MMSE ≥24. Prespecified additional analyses included effects week 160, subgroups (sex, age, race, ethnicity, depressive symptoms, risk, duration albuminuria), absolute changes performance. Participants, caregivers, people involved measurements, examinations adjudication, all masked to assignment. Results Of 6033 recruited from hospital care sites, 3163 (38.0% female, mean age/diabetes 64/7.6 years, 28.5, 54 [7.1%]) represent cohort. Over median 6.1 occurred 27.8% (449/1618, linagliptin) 27.6% (426/1545, glimepiride), OR 1.01 (95% CI 0.86, 1.18). Also, no differences observed 160 (OR 1.07 [0.91, 1.25]), between treatments across subgroups, for changes. Conclusions/interpretation In large, international relatively early diabetes elevated difference over years. Funding This sponsored Boehringer Ingelheim. Trial registration ClinicalTrials.gov NCT01243424. Graphical abstract