Eli Lilly and Company said that the once-weekly insulin efsitora alfa (efsitora) was found noninferior to once-daily insulin degludec in the QWINT-5 Phase 3 trial of adults with type 1 diabetes.
QWINT-5 assessed the effectiveness of efsitora, a once-weekly basal insulin, in type 1 diabetes patients who require both daily basal and multiple daily mealtime insulin injections.
The insulin is intended for weekly subcutaneous administration. Currently, the asset is in Phase 3 development for treating adults with type 1 and type 2 diabetes.
Degludec, developed by Novo Nordisk and branded as Tresiba, was approved by the US Food and Drug Administration (FDA) in 2015 for type 1 and type 2 diabetes.
The QWINT-5 trial features a 52-week treatment period, with the primary endpoint assessed at 26 weeks.
It enrolled 692 participants to randomly assign them to receive either efsitora weekly or insulin degludec daily, administered subcutaneously.
The trial demonstrated that the once-weekly basal insulin achieved the primary endpoint of non-inferior A1C reduction at week 26.
Specifically, efsitora led to a 0.53% reduction in A1C, compared to a 0.59% reduction with insulin degludec. This resulted in A1C levels of 7.37% and 7.32%, respectively.
In a key secondary endpoint, time in range was found similar for efsitora and insulin degludec during the four weeks leading up to week 26.
Lilly product development senior vice president Jeff Emmick said: “These results underscore the potential of efsitora to help some people living with type 1 diabetes lower their A1C with only one basal insulin injection per week, while also highlighting the complexity of treating this chronic disease.”
QWINT Phase 3 global clinical development programme for insulin efsitora alfa started in 2022.
This programme has enrolled over 4,000 individuals with type 1 or type 2 diabetes across five global registration studies.
Concurrently, Eli Lilly and Company announced the results from the QWINT-2 Phase 3 trial evaluating efsitora against degludec in adults with type 2 diabetes.
In the trial, the once-weekly basal insulin achieved the primary endpoint of non-inferior A1C reduction.
For the efficacy estimand, the insulin reduced A1C by 1.34%, while insulin degludec reduced it by 1.26%.
Additionally, efsitora provided 45 more minutes in range per day, a key secondary endpoint.
This was achieved without increasing the time spent in hypoglycaemia compared to degludec.
