Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial

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AIMS: This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice. MATERIALS AND METHODS: This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%-10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline. RESULTS: Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by -0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by -32.9 ± 46.3 mg/dL (-1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by -3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all p < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all p < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (p = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported. CONCLUSIONS: Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.