ml in type 1 diabetes

ǂthe ǂhead-to-head randomizedcontrolled InRange trial

Thomas Danne (Avtor), Steve V. Edelman (Avtor), Pratik Choudhary (Avtor), Eric Renard (Avtor), Jukka Westerbacka (Avtor), Bhaswati Mukherjee (Avtor), Valerie Pilorget (Avtor), Mathieu Coudert (Avtor), Richard Bergenstal (Avtor), Tadej Battelino (Avtor)

Povzetek

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.

Ključne besede

basal insulin;continuous glucose monitoring;glycaemic control;insulin analogues;randomized trial;type 1 diabetes;

Podatki

Jezik:	Angleški jezik
Leto izida:	2023
Tipologija:	1.01 - Izvirni znanstveni članek
Organizacija:	UL MF - Medicinska fakulteta
UDK:	616.379
COBISS:	143145987
ISSN:	1463-1326
Št. ogledov:	37
Št. prenosov:	4
Ocena:	0 (0 glasov)
Metapodatki:

Ostali podatki

Sekundarni jezik:	Slovenski jezik
Sekundarne ključne besede:	bazalni inzulin;stalno spremljanje glukoze;nadzor glikemije;inzulinski analogi;naključno preskušanje;sladkorna bolezen tipa 1;
Vrsta dela (COBISS):	Članek v reviji
Strani:	545-555 str.
Letnik:	ǂVol. ǂ25
Zvezek:	ǂiss. ǂ2
Čas izdaje:	2023
DOI:	10.1111/dom.14898
ID:	18140204