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Advancement Revealed: Phase 3 Trial Results Unveil Once-Weekly Insulin Efsitora Alfa (Efsitora)


Eli Lilly has announced the positive results from QWINT-2 and QWINT-4 Phase 3 clinical trials. The trial evaluated once-weekly Efsitora in insulin naïve adults with type 2 diabetes who require multiple daily insulin injections.

QWINT-2 randomized controlled trial evaluated the safety and efficacy of once-weekly Efsitora compared to once-daily insulin degludec for 52 weeks, in insulin naïve adults.

The trial met its primary endpoint of non-inferior A1C reduction with Efsitora compared to insulin degludec at week 52. Efsitora reduced A1C by 1.34%, resulting in an A1C of  6.87% compared to 1.26% reduction and an A1C of  6.95% with insulin degludec. In a key secondary endpoint, Efsitora was non-inferior to insulin degludec in A1C change among participants using and not using GLP-1 receptor agonists. Efsitora also improved time in range by 45 minutes without additional time in hypoglycaemia in comparison to insulin degludec.

QWINT-4, open label, randomized controlled trial evaluated the efficacy and safety of Efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. Participants received Efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously with insulin lispro. The trial met its primary endpoint of non-inferior A1C reduction with Efsitora compared to insulin glargine at week 26. The A1C was reduced by 1.07% in both the cases leading to A1C of 7.12% with efsitora and 7.11% with insulin glargine.

 

Looking ahead:

Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024.

Topline readouts from QWINT-1, QWINT-3 and QWINT-5 are anticipated in late 2024.

Ref:

 

Market intelligence:

In March 2024, Novo Nordisk announced that CHMP has adopted a positive opinion, recommending marketing authorisation for once-weekly basal insulin icodec for treatment of diabetes in adults. The positive opinion was based on the results from the ONWARDS Phase 3a clinical trial.

Icodec is to be discussed by the USFDA’s Endocrinologic and Metabolic Drugs Advisory Committee on 24 May, 2024. The Committee will discuss the safety and efficacy of insulin icodec whose proposed indication is to improve glycemic control in adults with diabetes mellitus.

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