Continuous glucose monitoring-based time-in-range usinginsulin glargine 300 units/ml versus insulin degludec100 units/ml in type 1 diabetesBattelino, Tadej (Avtor) Danne, Thomas (Avtor) Edelman, Steve (Avtor) Choudhary, Pratik (Avtor) Renard, Eric (Avtor) Westerbacka, Jukka (Avtor) Mukherjee, Bhaswati (Avtor) Pilorget, Valerie (Avtor) Coudert, Mathieu (Avtor) Bergenstal, Richard (Avtor) basal insulincontinuous glucose monitoringglycaemic controlinsulin analoguesrandomized trialtype 1 diabetesAim:To use continuous glucose monitoring (CGM)-based time-in-range (TIR) as a pri-mary efficacy endpoint to compare the second-generation basal insulin(BI) analogues insulin glargine 300 U/ml (Gla-300) and insulin degludec 100 U/ml(IDeg-100) in adults with type 1 diabetes (T1D).Materials and Methods:InRange was a 12-week, multicentre, randomized, active-controlled, parallel-group, open-label study comparing glucose TIR and variabilitybetween Gla-300 and IDeg-100 using blinded 20-day CGM profiles. The inclusioncriteria consisted of adults with T1D treated with multiple daily injections, using BIonce daily and rapid-acting insulin analogues for at least 1 year, with an HbA1c of7% or higher and of 10% or less at screening.Results:Overall, 343 participants were randomized: 172 received Gla-300 and 171 IDeg-100. Non-inferiority (10% relative margin)of Gla-300 versus IDeg-100 was shown for theprimary endpoint (percentage TIR≥70 to≤180 mg/dl): least squares (LS) mean (95% con-fidence interval) 52.74% (51.06%, 54.42%) for Gla-300 and 55.09% (53.34%, 56.84%) forIDeg-100; LS mean difference (non-inferiority): 3.16% (0.88%, 5.44%) (non-inferiorityP=.0067). Non-inferiority was shown on glucose total coefficient of variation (main second-ary endpoint): LS mean 39.91% (39.20%, 40.61%) and 41.22% (40.49%, 41.95%), respec-tively; LS mean difference (non-inferiority)5.44% (6.50%,4.38%) (non-inferiorityP< .0001). Superiority of Gla-300 over IDeg-100 was not shown on TIR. Occurrences ofself-measured and CGM-derived hypoglycaemia were comparable between treatmentgroups. Safety profiles were consistent with known profiles, with no unexpected findings.Conclusions:Using clinically relevant CGM metrics, InRange shows that Gla-300 isnon-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia andsafety profiles.a20232025-08-11 06:20:43Neznano198UDK: 616.379ISSN pri članku: 1463-1326DOI: 10.1111/dom.14898COBISS.SI-ID: 143145987asl