Frias JP, et al. - In patients with type 2 diabetes, researchers assessed the overall safety and adverse event (AE) profile of iGlarLixi, a titratable, fixed-ratio combination of insulin glargine (100 units/mL) and lixisenatide (33 μg/mL). Patient-level data from the phase 2 LixiLan proof-of-concept trial and the phase 3 LixiLan-L (insulin-experienced patients) and LixiLan-O (insulin-naïve patients) trials were collated to assess AEs correlated with iGlarLixi. Findings suggested that iGlarLixi has a safety profile consistent with that of its two active components insulin glargine and lixisenatide, with no pancreatitis or thyroid C cell tumors signals, and no black-box warning for iGlarLixi. No unexpected safety results were reported. Despite a greater reduction in glycated hemoglobin A1c, iGlarLixi had beneficial effects on glycemic control, with no increased risk of hypoglycemia. Furthermore, fewer gastrointestinal AEs were associated with iGlarLixi compared with lixisenatide alone. The rates of allergic reactions, malignancy, renal impairment and cardiovascular events among the treatment groups were low and comparable. Older age (≥ 65 years) and gender have no effect on effectiveness or safety.