A distinguished panel of experts reviewed the latest information on the development of weekly insulins, oral insulins, glucose-sensitive insulin, and the role of biosimilars and interchangeable insulins on Monday, June 6, at the 82nd Scientific Sessions.
The session, The Future of Insulin—Weekly, Oral, Smart, or Interchangeable Therapies, was livestreamed and can be viewed on-demand by registered meeting attendees at ADA2022.org. If you haven’t registered for the 82nd Scientific Sessions, register today to access the valuable meeting content.
Harpreet S. Bajaj, MD, MPH, consultant endocrinologist and Medical Director of Research at LMC Healthcare and Research Associate at Mount Sinai Hospital in Toronto, began the session with an update on the development of two novel once-weekly insulins—basal insulin Fc (BIF) and insulin icodec—both of which recently entered phase 3 clinical trials.
A phase 2 study that evaluated the safety and efficacy of BIF compared to insulin degludec in people with type 2 diabetes previously treated with oral antidiabetic drugs and a basal insulin found that BIF was noninferior to degludec for glycemic control as measured by change in A1C after 32 weeks, he said. Another phase 2 study, this one looking at two different approaches for switching to icodec in people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications, demonstrated that switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control.
“The phase 2 trial results of both BIF and icodec look promising,” Dr. Bajaj said. “Phase 3 trials for icodec are expected to be completed, possibly as soon as the end of this year, and the BIF trials are expected to be completed in 2024.”
George Grunberger, MD, Chairman of the Grunberger Diabetes Institute and Clinical Professor of Internal Medicine and Molecular Medicine and Genetics at Wayne State University School of Medicine, discussed several novel oral insulins currently being developed, including the oral insulin capsule ORMD-801.
“Phase 2 trials demonstrated that ORMD-801 significantly reduced A1C levels in people with type 2 diabetes who were inadequately controlled on other standard-of-care drugs,” Dr. Grunberger said. “It’s still too early to tell if this and other oral insulins being investigated are the future of diabetes treatment, but data from phase 3 trials over the next year or so will hopefully provide the answer.”
Michael A. Weiss, MD, PhD, MBA, Chair of Biochemistry and Molecular Biology at the Indiana University School of Medicine, discussed the development of glucose-sensitive insulin, or “smart insulin,” that can be activated through the use of a synthetic “switch” that can be opened or closed using a simple sugar sensor.
“The reason a glucose-responsive insulin is important is that the biggest barrier to the effective use of insulin, especially in type 1 diabetes, is the fear of the consequences of blood sugar going too low,” Dr. Weiss said.
While much more research and experimentation are needed, Dr. Weiss thinks the first smart insulins could be available within the next five years.
Rita Rastogi Kalyani, MD, MHS, Associate Professor of Endocrinology, Diabetes, and Metabolism at the Johns Hopkins School of Medicine, concluded the session with a discussion of insulin access and affordability, including the role of interchangeable biosimilar insulins.
“As the price of insulin continues to rise, individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to short- and long-term health consequences,” Dr. Kalyani said. “Biosimilars offer the opportunity to lower insulin prices overall, but the manufacturing process may be cumbersome. More biosimilars need to be developed in the future in order for full cost-savings to be realized for insulin.”