Weekly insulin efsitora alfa matches daily insulin in A1C reduction for type 1 diabetes

Eli Lilly and Company recently revealed comprehensive findings from the QWINT-5 phase 3 trial, assessing once-weekly insulin efsitora alfa (efsitora) against the daily insulin degludec in adults with type 1 diabetes. The detailed results were published in The Lancet and presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024.

The QWINT-5 trial demonstrated that efsitora met the primary endpoint by achieving a non-inferior reduction in A1C levels at the 26-week mark. Specifically, efsitora reduced A1C by 0.53%, while insulin degludec achieved a 0.59% reduction, resulting in final A1C levels of 7.37% and 7.32%, respectively.

One of the key secondary endpoints was the time in range, measured through continuous glucose monitoring (CGM), which showed comparable results for efsitora and insulin degludec in the four weeks leading up to week 26. Another secondary endpoint focused on the incidence of clinically significant or severe nocturnal hypoglycemic events, with similar rates reported for both insulins during the 52-week trial period.

Dr. Richard Bergenstal, executive director of the International Diabetes Center, remarked on the significance of the findings. He noted that a single weekly dose of basal insulin such as efsitora could potentially match the efficacy of daily basal insulin injections. Bergenstal emphasized the importance of further research to mitigate hypoglycemia and explore the potential of once-weekly insulin to personalize type 1 diabetes management.

In terms of safety, the trial noted that the combined rates of clinically significant or severe hypoglycemic events were 14.03 per patient-year for efsitora compared to 11.59 for insulin degludec over the 52 weeks. The data showed no prolonged hypoglycemia duration for efsitora according to CGM readings. Severe hypoglycemic events occurred at a rate of 0.14 per patient-year for efsitora, compared to 0.04 for insulin degludec. Interestingly, 64% of severe hypoglycemic events with efsitora happened within the first 12 weeks, with a decline in incidence in both groups after this period.

Adverse events were generally comparable between the groups, although efsitora had a higher rate of serious adverse events, driven primarily by severe hypoglycemic episodes.

Dr. Jeff Emmick, senior vice president of product development at Lilly, highlighted the enduring commitment the company has towards improving diabetes care. He expressed confidence in efsitora's potential to revolutionize diabetes management by reducing A1C levels with just one weekly basal insulin injection, while acknowledging the complexities of treating this chronic condition.

The QWINT clinical trial program, which began in 2022, has involved over 4,000 participants with type 1 and type 2 diabetes across five global studies. QWINT-5 is a multicenter, randomized, open-label study designed to compare the efficacy and safety of once-weekly efsitora to daily insulin degludec in individuals with type 1 diabetes. The trial spanned 52 weeks and involved 692 participants from various countries, including the U.S., Japan, and Poland, among others.

Insulin efsitora alfa is a fusion protein that combines a novel single-chain insulin variant with a human IgG2 Fc domain, designed for once-weekly administration. With a low peak-to-trough ratio, it aims to offer stable glucose levels throughout the week and is currently in phase 3 development for both type 1 and type 2 diabetes.

Lilly has been a pioneer in medical innovations for nearly 150 years and continues to focus on addressing significant health challenges through advanced scientific research and clinical trials. The company's ongoing efforts include providing accessible and affordable treatments while ensuring diversity in clinical trials.

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