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[The effectiveness of the fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) has been confirmed by several clinical trials in people with type 2 diabetes (T2DM). The aim of this study was to demonstrate the effectiveness of iGlarLixi treatment in improvement glycemic control in participants who were inadequately controlled on basal insulin using continuous glucose monitoring (CGM) data.

The primary endpoint of this 18-week, single-arm, open-label, phase 4 clinical trial was the change of blood glucose level time in range (TIR). The inclu­sion criteria were at least 3-year T2DM and 6-month treatment with basal insulin, HbA1c level ≥7.5% and ≤10% and fasting blood glucose level ≤7.8 mmol/l. CGM data recording was performed before the switch to iGlarLixi and at the 18th week. Dose titration of iGlarLixi was based on self-monitoring of blood glucose levels.

Overall 51 participants were treated with iGlarLixi and 34 participants had baseline and end-of-study CGM recordings (“per-protocol population”). The per-protocol population’s mean (SD) age was 66.4 (7.01) years and they have had T2DM for 16.6 (9.06) years at inclusion. The percentage of TIR increased from 71.8% (18.08) to 78.3% (12.36) (p=0.066), while the time above range (TAR) decreased significantly from 24.0% (18.96) to 9.9% (9.85; p<0.001). The percentage of time-below-range (TBR) increased from 4.2% (7.23) to 11.8% (13.48; p<0.001). The HbA1c level decreased from 8.4% (0.63) to 7.1% (0.91), and the fasting blood glucose levels also decreased.

This study confirmed the effectiveness of iGlarLixi using CGM data and provided numerous learnings for designing future CGM studies.]