Article Document Academic Article Information Content Entity Continuant Continuant Journal Article Entity Entity Generically Dependent Continuant 2025-05-06T14:35:48 RDF description of Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial - http://repository.healthpartners.com/individual/document-rn37500 10458 Lancet (London, England) <p>BACKGROUND: Insulin efsitora alfa (efsitora) is a once-weekly basal insulin. This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes. METHODS: This randomised, 52-week, parallel-design, open-label, treat-to-target non-inferiority study conducted at 82 global health-care centres, randomly assigned (1:1) adults (ie, those aged 鈮� 18 years) with type 1 diabetes glycated haemoglobin A(1c) (HbA(1c)) 7路0-10路0% (53路0-85路8 mmol/mol) to efsitora (n=343) or, degludec (n=349), both in combination with insulin lispro. The primary endpoint was the change in HbA(1c) from baseline to week-26 (non-inferiority margin=0路4%). The trial was registered at ClinicalTrials.gov (NCT05463744) and is completed. FINDINGS: Between Aug 12, 2022, and May 7, 2024, of 893 participants enrolled, 692 (77%) participants were randomly assigned to once-weekly efsitora or once-daily degludec, and 623 (90%) participants completed the study. Mean HbA(1c) decreased from 7路88% (62路66 mmol/mol) at baseline to 7路41% (57路5 mmol/mol) at week 26 with efsitora and from 7路94% (63路3 mmol/mol) at baseline to 7路36% (56路9 mmol/mol) at week 26 with degludec. Mean HbA(1c) change from baseline to week 26 was -0路51% with efsitora and -0路56% with degludec (estimated treatment difference 0路052%, 95% CI -0路077 to 0路181; p=0路43), confirming a non-inferiority margin of 0路4% for efsitora compared with degludec. Rates of combined level 2 (<54 mg/dL [3路0 mmol/L]) or level 3 severe hypoglycaemia were higher with efsitora compared with degludec (14路03 vs 11路59 events per patient year of exposure; estimated rate ratio 1路21, 95% CI 1路04 to 1路41; p=0路016) during weeks 0-52, with the highest rates during weeks 0-12. Severe hypoglycaemia incidence was higher with efsitora (35 [10%] of 343) versus degludec (11 [3%] of 349) during weeks 0-52. Overall incidence of treatment-emergent adverse events was similar across treatment groups. One death not related to the study treatment occurred in the degludec group. INTERPRETATION: In adults with type 1 diabetes, once-weekly efsitora showed non-inferior HbA(1c) reduction compared with daily insulin degludec. Higher rates of combined level 2 or level 3 hypoglycaemia and greater incidence of severe hypoglycaemia in participants treated with efsitora compared with participants treated with degludec might suggest the need for additional evaluation of efsitora dose initiation and optimisation in people with type 1 diabetes. FUNDING: Eli Lilly and Company.<p> 10.1016/s0140-6736(24)01804-x Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial document-rn37500 Clinical Trials 22975 39630 2024-09-30T22:02:38.29-05:00 Adverse Effects Diabetes Randomized Controlled Trials Drugs and Drug Therapy Comparative Studies 404 public