Advancing type 2 diabetes therapy with iGlarLixi in older people: Pooled analysis of four randomized controlled trials

Aim: To assess the efficacy and safety of iGlarLixi in older people (>= 65 years) with type 2 diabetes (T2D) advancing or switching from oral agents, a glucagon-like peptide-1 receptor agonist (GLP-1RA), or basal insulin.Materials and Methods: The data of participants aged <65 years and >= 65 years from four LixiLan trials (LixiLan-O, LixiLan-G, LixiLan-L, SoliMix) were evaluated over 26 or 30 weeks.Results: Participants aged <65/>= 65 years (n = 1039/n = 497) had a mean baseline body mass index of 31.4 and 30.7 kg/m(2 )and glycated haemoglobin (HbA1c) concentration of 66 mmol/mol (8.2%) and 65 mmol/mol (8.1%), respectively. Least squares mean HbA1c change from baseline to end of treatment (EOT) was -14.32 mmol/mol (-1.31%) (95% confidence interval [CI] -14.97, -13.77 [-1.37%, -1.26%]) for those aged <65 years and -13.66 mmol/mol (-1.25%) (95% CI -14.54, -12.79 [-1.33%, -1.17%]) for those aged >= 65 years. At EOT, achievement of HbA1c targets was similar between the group aged <65 years and the group aged >= 65 years: <53 mmol/mol (<7%) (59.0% and 56.5%, respectively), <59 mmol/mol (<7.5%) (75.5% and 73.0%, respectively) and <64 mmol/mol (<8%) (83.8% and 84.1%, respectively). The incidence and event rate of American Diabetes Association Level 1 hypoglycaemia during the studies were also comparable between the two groups: 26.7% and 28.2% and 1.7 and 2.1 events per patient-year for the group aged <65 years and the group aged >= 65 years, respectively. A clinically relevant reduction in HbA1c (>1% from baseline for HbA1c >= 64 mmol/mol [>= 8%] or >= 0.5% from baseline for HbA1c <64 mmol/mol [<8%]) without hypoglycaemia was attained by 50.0% and 47.6% of participants aged <65 years and >= 65 years, respectively. Adverse events were similar between the two age groups.Conclusion: siGlarLixi is a simple, well-tolerated, once-daily alternative for treatment advancement in older people with T2D that provides significant improvements in glycaemic control without increasing hypoglycaemia risk, thus reducing the treatment burden.