The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively.
Eli Lilly on Tuesday unveiled data from two late-stage studies, further building the case for its once-weekly insulin efsitora in patients with diabetes. The pharma presented its findings at the 2024 Annual Meeting of European Association for the Study of Diabetes.
In QWINT-2, Lilly tested efsitora in insulin-naïve type 2 diabetes patients versus daily insulin degludec. Results showed that the once-weekly injection could lower A1C by 1.34%, compared with the 1.26% reduction in degludec patients—an effect that was non-inferior, according to the company. A1C level at 52 weeks was 6.87% after efsitora treatment and 6.95% in degludec comparators.
Efsitora continued to match degludec in patients who were and were not taking GLP-1 receptor agonists, resulting in non-inferior reductions in A1C.
QWINT-2 results also showed that patients treated with the weekly insulin spent 45 minutes more in time in range per day versus degludec, a key secondary endpoint. Efsitora’s safety profile was similar to daily insulin, resulting in severe hypoglycemic episodes, versus six in the degludec arm. Time in hypoglycemia was not increased.
“With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora,” Jeff Emmick, Lilly’s senior vice president of product development, said in a statement.
The QWINT-2 readout adds to growing evidence supporting efsitora in type 2 diabetes. Last week, Lilly also posted data drops from QWINT-1 and QWINT-3, demonstrating that the once-weekly efsitora could match daily injections in patients who were insulin-naïve and in those who were switching to a weekly schedule from daily basal insulin.
Lilly is also positioning efsitora as a potential once-weekly treatment for type 1 diabetes. At the EASD Annual Meeting, the pharma also revealed findings from the Phase III QWINT-5 study, which established the non-inferiority of efsitora versus daily degludec injections.
At week 26, patients treated with efsitora saw a 0.53% drop in A1C, versus the 0.59% reduction in degludec comparators. A1C levels at this time point was 7.37% and 7.39% in the respective treatment arms. Efsitora also matched daily degluec in terms of the percent of time spent in range in the four-week period leading up to the 26-week follow-up.
The rate of patients-reported clinically significant or severe hypoglycemic episodes was slightly higher in patients treated with efsitora, though the duration of hypoglycemia was comparable between treatments. Severe hypoglycemic events per patient-year of exposure were also slightly more frequent in the efsitora group.
Findings from the QWINT program could help put Lilly ahead of Novo Nordisk, which failed to win the FDA’s approval for its once-weekly basal insulin icodec in July 2024. The regulator pointed to manufacturing issues and raised concerns about icodec’s benefit/risk profile in type 1 diabetes.
