Introduction: The IDEAL RCT examined the efficacy and safety of MDI de-intensification into once-daily administered iGlarLixi in people with type 2 diabetes (PwT2D) and showed that it provides comparable glycemic control with the benefits of reduction of body weight, total daily insulin dose and number of insulin injections. Here we report CGM outcomes from the trial.
Methods: IDEAL was a 5-centre, open-label, parallel-group, phase 4 RCT with a 24-week active treatment period. Participants were randomized in a 1:1 fashion into iGlarLixi or continuation with MDI and were applied professional CGM (Freestyle Libre Pro iQ) before the onset (BL) and for the last 2 weeks of the treatment period (W24). Participants in whom ≥ 72 hours of CGM data were available were included in the analysis.
Results: Altogether 73/91 (80.2%) of IDEAL participants were analyzed. Median (IQR) %TIR increased in the iGlarLixi group (70 [57 - 88] at BL vs 80 [61 - 92] at W24, p = 0.039), but remained unchanged in the MDI group (78 [67 - 89] vs 82 [64 - 89], p = 0.728). In the iGlarLixi group reductions in %TAR (26 [11 - 44] vs 13 [6 - 35], p = 0.04), % of time in level 2 hyperglycemia (2 [1 - 9] vs 1 [0 - 4], p = 0.019), mean glucose (8.6 [7.4 - 10.1] vs 7.7 [6.9 - 9.2] mmol/L, p = 0.012) and glycemia risk index (GRI) (26 [10 - 46] vs 19 [8 - 35], p = 0.036) were detected. Median (IQR) %TBR (< 3.9 mmol/L) remained unchanged in iGlarLixi group (0 [0 - 1] vs 1 [0 - 2], p = 0.337) and MDI group (0.5 [0 - 2] vs 1 [0 - 3.75], p = 0.147). Statistically significant differences between the changes (BL - W24) in the following CGM metrics (iGlarLixi vs MDI) were observed: %CV (-0.8 [-3.4 - 0.75] vs 1.4 [-1.2 - 3.3], p = 0.016) and GRI (-3.2 [-22.4 - 2.4] vs 1.6 [-6.25 - 10.6], p = 0.045).
Conclusion: Insulin therapy de-intensification from MDI into iGlarLixi in PwT2D showed an improvement in CGM outcomes vs baseline (TIR, TAR, level 2 hyperglycemia, mean glucose and GRI) and vs continuation with MDI (glycemic variability and GRI) without increase of time spent in hypoglycemia.
P. Novodvorsky: Speaker's Bureau; Sanofi, Boehringer-Ingelheim. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Novo Nordisk A/S. Research Support; Sanofi. Speaker's Bureau; Abbott, Medtronic, Berlin-Chemie AG, Viatris Inc., Novartis AG. L. Thieme: None. I. Lankova: None. A. Veselá: None. E. Zahumensky: None. T. Edelsberger: None. M. Löblová: None. F. Hrubý: None. M. Mraz: None. M. Haluzik: Advisory Panel; Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Johnson & Johnson Medical Devices Companies. Consultant; Merck & Co., Inc., Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Johnson & Johnson Medical Devices Companies, Novatin. Research Support; Sanofi. Speaker's Bureau; Sanofi, Novo Nordisk.
Sanofi
