Amylin Pharmaceuticals, Inc., Eli Lilly and Company, and Alkermes, Inc. announced results from a 52-week open-label clinical study that showed the durable efficacy of exenatide once weekly, a long-acting release formulation of exenatide.
Patients taking exenatide once weekly over the course of one year sustained a similar improvement in glucose control compared to those receiving treatment for 30 weeks. This study also showed that patients who switched from Byetta (exenatide) injection after 30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma glucose.
Seventy-four per cent of all patients in the study achieved an endpoint A1C of 7 per cent or less at 52 weeks. Patients in both treatment groups experienced a statistically significant and sustained average weight loss of 9.5 pounds over 52 weeks. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.
Byetta is indicated as adjunctive therapy to improve glycaemia control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycaemia control.
"Diabetes is a lifelong condition that requires constant management of blood glucose or blood sugar as well as weight. In Duration-1 trial, patients significantly reduced their blood glucose levels and, on average, lost a total of over nine pounds. These improvements were sustained for a year," said John B. Buse, MD, PhD, Professor of Medicine, director of the Diabetes Care Center, and Chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "Importantly, the study results also showed that steady-state levels of exenatide may result in improvements in a variety of glucose parameters. If approved, exenatide once weekly may provide patients with a treatment option that is on board 24 hours a day, seven days a week, helping to manage their blood sugar and, secondarily, their weight".
Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.