Effectiveness of IGlarLixi, a Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide, in People with Type 2 Diabetes.

Abstract

IntroductionThe latest Position Statement of the American Diabetes Association/European Association for the Study of Diabetes proposes the use of a fixed-ratio combination (FRC) of a long-acting basal insulin and a glucagon-like peptide-1 receptor agonist as part of treatment intensification. This study aimed to assess the effectiveness of the insulin glargine + lixisenatide (iGlarLixi) FRC on glycaemic control and hypoglycaemia in real-life settings.MethodsThis non-interventional, 26-week study included participants aged 18–80 years with suboptimally controlled type 2 diabetes (T2D) using oral antidiabetics (OADs) ± basal insulin therapy. The primary efficacy endpoint was the proportion of participants who achieved at least a 1% decrease in glycated haemoblobin (HbA1c) level from baseline to week 26.ResultsOf the 441 participants eligible for entry into the study, 353 were included in the efficacy analyses. These individuals were switched from OADs without (282 [79.9%]) or with (71 [20.1%]) insulin-based treatment. A reduction in HbA1c of at least 1.0% (primary endpoint) was achieved by 215 subjects (60.9%). All glycaemic variables (mean ± standard deviation) improved significantly during follow-up (HbA1c, from 8.9 ± 1.31 to 7.4 ± 0.97%; fasting blood glucose, from 9.0 ± 2.18 to 6.9 ± 1.23 mmol/L; postprandial blood glucose, from 11.3 ± 2.33 to 8.5 ± 1.46 mmol/L; p < 0.001 for all). Body weight also decreased during follow-up, from 90.5 ± 18.03 to 88.2 ± 17.75 kg (p < 0.001). Overall, 41 participants (9.3% of the safety population) self-reported 101 non-severe hypoglycaemic episodes (incidence rate 0.498 events/person-year). There were no severe hypoglycaemic episodes reported. Gastrointestinal adverse events were reported by five participants (1.1% of the safety population). The vast majority (96.6%) of the study population continued iGlarLixi treatment after the final visit.ConclusionThe results of this non-interventional study confirmed the efficacy results of the randomized controlled trial programme of the iGlarLixi FRC in a real-life setting. iGlarLixi significantly improved glycaemic control in association with a low frequency of hypoglycaemia and gastrointestinal adverse events in a heterogeneous population of participants with T2D suboptimally controlled with OADs ± basal insulin.