Time‐in‐range derived from self‐measured blood glucose in people with type 2 diabetes advancing to iGlarLixi : A participant‐level pooled analysis of three phase 3 LixiLan randomized controlled trials

Abstract Aim To evaluate the efficacy of a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D) using derived time‐in‐range (dTIR). Methods Participant‐level data from LixiLan‐L, LixiLan‐O and LixiLan‐G were pooled and dTIR (70‐180 mg/dL), derived time‐above‐range (> 180 mg/dL) and derived time‐below‐range (dTBR; < 70 mg/dL) were calculated from participant seven‐point self‐monitored blood glucose profiles. Results This pooled analysis included data from 2420 participants receiving iGlarLixi ( n = 1093), iGlar ( n = 836), Lixi ( n = 234) or a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) ( n = 257). Numerically greater improvements in least square (LS) means dTIR were seen from baseline to end of treatment (EOT) with iGlarLixi (25.7%) versus iGlar (15.8%), Lixi (11.7%) or GLP‐1 RA (16.2%). At EOT, the mean (standard deviation) dTBR was 0.71% ± 3.4%, 0.61% ± 3.2%, 0.08% ± 1.0% and 0.0% ± 0.0% for iGlarLixi, iGlar, Lixi and GLP‐1 RA, respectively. In a subgroup analysis, participants aged younger than 65 years ( n = 1690) and 65 years or older ( n = 713) showed numerically greater improvements in LS means dTIR from baseline to EOT with iGlarLixi versus iGlar, Lixi or GLP‐1 RA. Conclusions iGlarLixi achieved improvements in dTIR, with low dTBR values, providing further evidence to inform clinical outcomes with the use of iGlarLixi.