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Continuous glucose monitoring-based time-in-range usinginsulin glargine 300 units/ml versus insulin degludec100 units/ml in type 1 diabetes [Elektronski vir] : the head-to-head randomizedcontrolled InRange trialBattelino, Tadej ...Aim: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.Source: Diabetes, obesity & metabolism. - ISSN 1463-1326 (Vol. 25, iss. 2, [article no.] 14898, 2023, 545-555 str.)Type of material - e-article ; adult, seriousPublish date - 2023Language - englishCOBISS.SI-ID - 143145987
Author
Battelino, Tadej |
Danne, Thomas, 1959- |
Edelman, Steve |
Choudhary, Pratik |
Renard, Eric |
Westerbacka, Jukka |
Mukherjee, Bhaswati |
Pilorget, Valerie |
Coudert, Mathieu |
Bergenstal, Richard
Topics
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
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Database name | Field | Year |
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Battelino, Tadej | 13023 |
Danne, Thomas, 1959- | |
Edelman, Steve | |
Choudhary, Pratik | |
Renard, Eric | |
Westerbacka, Jukka | |
Mukherjee, Bhaswati | |
Pilorget, Valerie | |
Coudert, Mathieu | |
Bergenstal, Richard |
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