Basal Insulin Fc(Eli Lilly & Co.)

FRIDAY, Sept. 13, 2024 -- Once-weekly efsitora is noninferior to once-daily degludec for reducing glycated hemoglobin levels in adults with type 2 diabetes who have not received insulin, according to a study published online Sept. 10 in the New England Journal of Medicine to coincide with the annual meeting of the European Association for the Study of Diabetes, held from from Sept. 9 to 13 in Madrid. Carol Wysham, M.D., from the MultiCare Rockwood Center for Diabetes and Endocrinology in Spokane, Washington, and colleagues conducted a 52-week, treat-to-target trial involving adults with type 2 diabetes who had not previously received insulin. Participants were randomly assigned to receive efsitora (466 patients) or degludec (462 patients). The researchers found that from baseline to week 52, there was a decrease in the mean glycated hemoglobin level from 8.21 to 6.97 percent with efsitora and from 8.24 to 7.05 percent with degludec (estimated treatment difference, 0.09 percentage points), with the results demonstrating noninferiority. In participants using and not using glucagon like peptide-1 receptor agonists, efsitora was noninferior to degludec with respect to change in the glycated hemoglobin level. The percentage of time that the glucose level was within target range was 64.3 and 61.2 percent with efsitora and degludec, respectively (estimated treatment difference, 3.1 percentage points). The rate of combined clinically significant or severe hypoglycemia was 0.58 and 0.45 events per participant-year of exposure with efsitora and degludec, respectively (estimated rate ratio, 1.30). "Noninferiority to once-daily degludec with respect to the change in the glycated hemoglobin level from baseline to week 52 was shown," the authors write. Several authors disclosed ties to the pharmaceutical industry, including Eli Lilly, which funded the study.

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.