Results from the PIONEER Program Trials will be presented at 9:45 a.m. Tuesday in N-Hall E (North, Exhibition Level). ADAMeetingNews.org asked study investigator John B. Buse, MD, PhD, to discuss the background, objective, and significance of the studies. Dr. Buse is Professor of Medicine, Director of the Diabetes Care Center, and Chief of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill.
Dr. Buse: Fundamentally, we know that GLP-1 receptor agonists such as semaglutide are powerful glucose-lowering drugs that do not cause hypoglycemia and are associated with weight loss. Furthermore, we know that the class seems to be associated with improvements in cardiovascular risk in patients with pre-existing cardiovascular disease. However, many patients do not benefit from these drugs because they are injected and, as a result, often are not selected early in the course of the disease.
Dr. Buse: The goal of the PIONEER program is to demonstrate the safety and efficacy of an oral formulation of semaglutide, the first oral drug to work on this system. The PIONEER trial program enrolled more than 8,000 people with type 2 diabetes in 10 global clinical trials. Subjects were prescribed oral semaglutide on an empty stomach first thing in the morning.
Dr. Buse: The GLP-1 receptor agonists are arguably the most powerful glucose-lowering and weight-lowering medications that we have. In a number of trials, it’s been shown that these drugs seem to reduce the risk of heart attack, stroke, and, in some cases, cardiovascular death. However, there are some people who are reluctant to take the medication because it’s currently only available as an injection, which is a barrier to using this otherwise good class of drugs.
Oral semaglutide is the first GLP-1 receptor agonist for oral administration. It has been submitted for approval to the U.S. Food and Drug Administration and, potentially, could be approved and available by the end of the year or early next year. If the drug is approved, because it is administered orally, it has the potential to be more frequently used early in the course of disease, and perhaps will become the preferred agent in the class.