Eli Lilly’s insulin candidate efsitora alfa has achieved its main goals in a further two trials, which belong to the QWINT phase 3 development program. These two trials, QWINT-2 and QWINT-5, mainly looked at the change in A1C, an indicator of the patient’s glycaemic control.
The data was published in The New England Journal of Medicine and The Lancet. The results were also presented at the European Association for the Study of Diabetes conference in Spain.
Lilly’s vice president also stated that these are cumulative to other positive outcomes from the previous trials, namely QWINT-1 and QWINT-3 together with QWINT-4, brought out in May. The overall outcomes of the QWINT program indicate the efficacy of efsitora as a once-weekly insulin for Type 2 diabetes patients
In the QWINT-2 trial, efsitora is tested against insulin degludec in adult patients with T2DM who are switching from oral antidiabetic drugs to insulin. Efsitora proved to meet the primary objective for non-inferiority and acted similarly to NovoLog in decreasing A1C levels. In particular, the change in the average A1C level in patients on efsitora was a 1.34% reduction, compared to 1.62% for patients on degludec. The average A1C levels were 6.87% for efsitora patients and 6.95% for dugludec patients. Moreover, efsitora gave 45 more minutes of hypothesized target blood glucose level without an increased risk of hypoglycemia.
In terms of safety, the risk level of efsitora matched that of degludec; therefore, no serious low blood sugar events in the efsitora group, a total of six hypoglycemia reported in the daily insulin group.
The QWINT-5 trial, however, assessed efsitora to patients with type 1 diabetes who need basal insulin bolus doses and multiple prandial doses. In the trial, efsitora brought an average A1C decrease of 0.53%, a little lower than the 0.59% decrease brought by degludec. This shows that both treatments have a similar time period spent within the target range of blood glucose.
A once-weekly insulin could mean 313 fewer injections per year for diabetes patients, which may translate into better compliance with their treatment regimes.