20.500.12556/RUL-144586 Continuous glucose monitoring-based time-in-range using insulin glargine 300 units/ml versus insulin degludec 100 units/ml in type 1 diabetes the head-to-head randomized controlled InRange trial Aim: To use continuous glucose monitoring (CGM)-based time-in-range (TIR) as a primary 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 variability between Gla-300 and IDeg-100 using blinded 20-day CGM profiles. The inclusion criteria consisted of adults with T1D treated with multiple daily injections, using BI once daily and rapid-acting insulin analogues for at least 1 year, with an HbA1c of 7% 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 the primary endpoint (percentage TIR ≥ 70 to ≤ 180 mg/dl): least squares (LS) mean (95% confidence interval) 52.74% (51.06%, 54.42%) for Gla-300 and 55.09% (53.34%, 56.84%) for IDeg-100; LS mean difference (non-inferiority): 3.16% (0.88%, 5.44%) (non-inferiority P = .0067). Non-inferiority was shown on glucose total coefficient of variation (main secondary endpoint): LS mean 39.91% (39.20%, 40.61%) and 41.22% (40.49%, 41.95%), respectively; LS mean difference (non-inferiority) −5.44% (−6.50%, −4.38%) (non-inferiority P < .0001). Superiority of Gla-300 over IDeg-100 was not shown on TIR. Occurrences of self-measured and CGM-derived hypoglycaemia were comparable between treatment groups. Safety profiles were consistent with known profiles, with no unexpected findings. Conclusions: Using clinically relevant CGM metrics, InRange shows that Gla-300 is non-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia and safety profiles. basal insulin continuous glucose monitoring glycaemic control insulin analogues randomized trial type 1 diabetes bazalni inzulin stalno spremljanje glukoze nadzor glikemije inzulinski analogi naključno preskušanje sladkorna bolezen tipa 1 true false true Angleški jezik Slovenski jezik Članek v reviji 2023-03-02 14:14:44 2023-03-02 14:14:51 2023-03-03 03:36:44 0000-00-00 00:00:00 2023 0 0 Str. 545-555 iss. 2 Vol. 25 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.379 1463-1326 10.1111/dom.14898 143145987 Diabetes_Obesity_Metabolism_-_2022_-_Battelino_-_Cont.pdf Diabetes_Obesity_Metabolism_-_2022_-_Battelino_-_Cont.pdf 1 E61ACF940EC08F531587686B323901E7 3eedc5c453a924dd15a2695622920e11364a258c0894c4ec877a26a3f86b1e43 ee65be54-b8fc-11ed-a314-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=167004 https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14898 1 33d5de62-b8fc-11ed-a314-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=167003 Medicinska fakulteta 0 0 0