By Colin Kenny, Editor – Diabetes Distilled
The CARdiovascular Outcome Study of LINAgliptin versus glimepiride in patients with type 2 diabetes (CAROLINA) trial is the last planned cardiovascular outcome trial on a dipeptidyl peptidase 4 inhibitor. Researchers found that there were no substantial differences in cardiovascular events between linagliptin and glimepiride, although they found a significantly higher risk of hypoglycaemia and modest weight gain in the glimepiride group.
The CAROLINA trial was conducted from 2010 to 2018 at more than 600 sites in 43 countries. It included 6,033 adult participants aged 40 to 85 years who had type 2 diabetes. The median duration of diabetes was 6.2 years. Participants had either an increased risk of or established cardiovascular disease. They were randomly assigned to receive a 5-mg daily dose of linagliptin or a daily dose of up to 4 mg glimepiride, as well as their usual diabetes medications.
During the study period, 11.8% of the linagliptin group and 12% of the glimepiride group experienced a cardiovascular event (non-fatal stroke, non-fatal myocardial infarction or cardiovascular death). Linagliptin had similar overall effects on HbA1cto glimepiride but reduced the relative risk of hypoglycaemia by 77%: 10.6% of patients treated with linagliptin and 37.7% of patients taking glimepiride experienced hypoglycaemic incidents. Added to this, there was modest reduction in weight in the group taking linagliptin.
Researchers concluded that linagliptin was non-inferior to glimepiride for cardiovascular events in people with type 2 diabetes and cardiovascular risk. The results of the CAROLINA trial – which ran parallel to the Cardiovascular And Renal Microvascular outcome study with LINAgliptin in patients with type 2 diabetes mellitus (CARMELINA), the results of which have already been published – were announced during the American Diabetes Association meeting in June.
