Similar efficacy and safety in type 2, higher incidence of hypoglycemia in type 1
A pair of clinical trial results have shown that there would be no major problems if diabetes patients were to replace their daily insulin injections with a once-a-week injection. This is based on the research results of a research team in the United States, which were announced at the annual meeting of the European Association for the Study of Diabetes (EASD), held in Madrid, Spain from the 9th to the 13th (local time), and was reported on the 11th by the health and medical webzine ‘Health Day’.
Efsitora alfa, a new insulin injection developed by Eli Lilly, an American pharmaceutical company, is a once-weekly injection. The research team conducted two clinical trials comparing the effects of efsitora alfa with the daily standard treatment injection degludec on 623 patients with type 1 diabetes, which is mainly caused by immune system disorders, and 928 patients with type 2 diabetes, which is caused by insulin resistance.
In two clinical trials that lasted 52 weeks, researchers randomly assigned participants to take either Epsitora or Degludec insulin. The results showed that Epsitora had a similar effect on controlling blood sugar levels as Degludec, but there was a difference in the frequency of hypoglycemia.
In clinical trials for type 2 diabetes, no statistically significant difference was found between epcitora and degludec with respect to hypoglycemia. However, in clinical trials for type 1 diabetes, the incidence of hypoglycemia was more than three times higher in the epcitora injection group (10%) than in the degludec injection group (3%).
“Once-weekly insulin injections could simplify dosing and lower the barrier to starting insulin therapy by reducing injection burden compared to once-daily insulin injections,” said Dr. Carol Wisham, of the Rockwood Diabetes and Endocrinology Center in Boston, who led the type 2 diabetes trial. “Epsitora has the potential to reduce treatment burden and improve adherence while lowering glycated hemoglobin (A1C) levels. These results are meaningful for patients with type 2 diabetes who are looking for a once-weekly option.”
“Patients with type 1 diabetes who require daily insulin do so either with an automated insulin delivery system or through daily basal insulin injections and multiple mealtime insulin injections,” said Dr. Richard Bergenstal of Health Partners Research Institute in the U.S., who led the type 1 diabetes clinical trial. He said that while the weekly Epsitora injections showed similar reductions in A1C as daily injections, “more studies are needed to determine the optimal dose to maintain efficacy while reducing the risk of hypoglycemia.”
In clinical trials for type 2 diabetes, Epsitora was shown to be effective even when diabetes patients were taking a glucagon-like peptide-1 (GLP-1) drug, such as Ozempic. “Given the growing global use of GLP-1 receptor agonists and current treatment guidelines and recommendations to integrate them early in treatment, these results suggest that Epsitora may be an effective and safe addition to such treatment regimens,” Dr. Wisham and colleagues wrote in a statement.
The results of the two clinical trials were published in two journals on September 10. The results of the type 2 diabetes trial were published in the New England Journal of Medicine (NEJM), and the results of the type 1 diabetes trial were published in the Lancet.
Source: kormedi.com