Basal Insulin Fc(Eli Lilly & Co.)

WEDNESDAY, Sept. 11, 2024 -- Weekly insulin shots can help control both type 1 and type 2 diabetes as well as daily injections do, a pair of clinical trials have found. A new class of insulin called efsitora alfa has been designed to require injections only once a week, researchers said. Two phase 3 trials presented Tuesday at the European Association for the Study of Diabetes annual meeting in Madrid show that efsitora is as safe and effective as standard daily insulin shots: “A once-weekly insulin has the potential to simplify dose administration and diminish barriers to starting insulin therapy by means of a reduction in injection burden as compared with a once-daily insulin,” wrote the team behind the type 2 diabetes trial, which was led by Dr. Carol Wysham , an endocrinologist with the MultiCare Rockwood Center for Diabetes and Endocrinology in Spokane, Wash. "Traditionally, basal insulins are dosed once a day -- a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes," said Wysham said in a news release from drug maker Eli Lily. "Efsitora has the potential to address treatment burden and improve adherence -- all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins." In both clinical trials, which lasted 52 weeks, researchers randomly assigned participants to taking either efsitora or degludec insulin. The major difference in the results between the two trials involved hypoglycemic (low blood sugar) events. The type 2 diabetes trial found no statistically significant difference between efsitora and degludec when it came to hypoglycemia. But hypoglycemia occurred more often for type 1 diabetics taking efsitora (10%) compared with degludec (3%), results show. More work is needed to figure out the best dose “to maintain efficacy while mitigating the risk of hypoglycemia with weekly efsitora treatment in people with type 1 diabetes,” concluded the type 1 diabetes trial team led by Dr. Richard Bergenstal , executive director of the HealthPartners Institute's International Diabetes Center in Minneapolis. "People with type 1 diabetes need insulin every day. Currently, they can deliver the insulin using an automated insulin delivery system or by taking a daily basal insulin injection and multiple mealtime insulin injections each day," Bergenstal explained in an Eli Lilly news release . "This new data shows that with one dose a week of basal insulin, efsitora was able to achieve a similar A1C reduction as taking an injection of one of the most used background insulins every day. I look forward to further evaluation of these data, including ways to minimize hypoglycemia, so once-weekly insulin can be one option for personalizing the management of type 1 diabetes." The type 2 diabetes trial also found that efsitora worked well in diabetics even if they were taking a GLP-1 drug like Ozempic. “Given treatment guidelines and recommendations to incorporate GLP-1 receptor agonists earlier in treatment, along with their growing use worldwide, it is relevant to show that efsitora can be effectively and safely added to such therapy,” Wysham’s team concluded in a meeting news release. Type 1 diabetes is an inherited condition in which the immune system destroys or damages the body’s ability to make insulin. People with type 2 diabetes develop resistance to insulin, which also can destroy or damage the ability to make insulin. Results from the type 2 diabetes trial were published Sept. 10 in the New England Journal of Medicine , while results from the type 1 trial were published Sept. 10 in The Lancet . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

iStock, JHVEPhoto 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 pro 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 pro type 1 diabetes.