Efficacy of iGlarLixi, a fixed-ratio combination of insulin glargine and lixisenatide, in patients with type 2 diabetes stratified as at high or low risk according to HEDIS measurements

The Healthcare Effectiveness Data and Information Set (HEDIS) measurements assess glycaemic goal attainment in patients with type 2 diabetes, incorporating factors including age and health status. Healthier patients are assigned a glycated haemoglobin (HbA1c) goal of <7% (low-risk [LR]) and individuals aged >65 years or with comorbidities are assigned a goal of <8% (high-risk [HR]). This post-hoc analysis assessed the safety and efficacy of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, in 1898 patients from the phase 3 LixiLan-L and LixiLan-O clinical trials, retrospectively classified as LR (n = 1181) or HR (n = 717). iGlarLixi was more effective in reducing HbA1c than comparators in both LR and HR patients across the LixiLan-L trial (change from baseline, 1.1% vs -0.6% for iGlar in both groups; P < 0.001) and the LixiLan-O trial (change from baseline, LR/HR -1.6%/-1.4% vs -1.3%/-1.2% for iGlar and -0.8%/-0.9% for lixisenatide; P < 0.01). iGlarLixi treatment significantly reduced postprandial glucose in both LR and HR patients (P < 0.001). The incidence of hypoglycaemia did not differ between risk categories in any treatment group.