Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results

Cristian Guja, Francesco Giorgino, Lawrence Blonde, Amar Ali, Martin Prázný, Juris J Meier, Elisabeth Souhami, Robert Lubwama, Chen Ji, Julio Rosenstock, Cristian Guja, Francesco Giorgino, Lawrence Blonde, Amar Ali, Martin Prázný, Juris J Meier, Elisabeth Souhami, Robert Lubwama, Chen Ji, Julio Rosenstock

Abstract

Introduction: iGlarLixi, the once-daily fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, robustly improves glycaemic control in adults with type 2 diabetes irrespective of previous treatment [oral antihyperglycaemic drugs (OADs), basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs)]. Sodium-glucose co-transporter-2 inhibitors (SGLT2is) are a recommended treatment option for people with type 2 diabetes with cardiovascular disease, kidney disease and/or heart failure because of their cardio- and renoprotective benefits. Herein, we assessed the effects of concomitant iGlarLixi and SGLT2i therapy.

Methods: We conducted subgroup analyses according to SGLT2i use in: (1) adults with suboptimally controlled type 2 diabetes on GLP-1 RAs and OADs switching to iGlarLixi in the 26-week LixiLan-G randomised controlled trial (RCT; NCT02787551) and (2) adults switching to or adding iGlarLixi in a 6-month, retrospective real-world evidence (RWE) observational study using data from the US Optum-Humedica electronic medical records database. Changes in HbA1c and hypoglycaemia prevalence and event rates were assessed.

Results: There were no major differences in baseline characteristics for those who initiated iGlarLixi while already using SGLT2i (n = 346) and those initiating iGlarLixi without concomitant SGLT2i therapy (n = 1285). HbA1c reductions from baseline to time of assessment and hypoglycaemia prevalence and event rates were similar for iGlarLixi users regardless of SGLT2i therapy.

Conclusion: Evidence from an RCT and an RWE analysis supports the efficacy/effectiveness and safety of iGlarLixi when used concomitantly with SGLT2i.

Trial registration: NCT02787551.

Keywords: Basal insulin; GLP-1 analogue; Glycaemic control; Hypoglycaemia; SGLT2 inhibitor; Type 2 diabetes; iGlarLixi.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Glycaemic control results by study: a LixiLan-G subgroup analysisa, b RWE study. aAll participants in LixiLan-G were also receiving metformin; all data are presented for the mITT population, defined as all randomised participants with a baseline assessment and at least one post-baseline assessment for any primary or secondary efficacy variables. bBaseline data are presented as mean ± SD. cTwo-hour PPG was measured during a standardised meal test. BL baseline; FPG fasting plasma glucose; iGlarLixi a fixed-ratio combination of insulin glargine 100 U/ml and the glucagon-like peptide-1 receptor agonist, lixisenatide; LS least squares; SD standard deviation; SE standard error; mITT modified intent to treat; PPG post-prandial plasma glucose; RWE real-world evidence; SGLT2i sodium-glucose co-transporter-2 inhibitor

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Source: PubMed

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