A panel of researchers and other experts took part in a discussion on new and upcoming insulin products — like once-weekly, oral, and glucose-sensitive insulins — at the 2022 Scientific Sessions of the American Diabetes Association (ADA), as described in a news release from the organization.
While inhaled insulin has been available in the United States for several years, the overwhelming choice for doctors and patients has always been different forms of injected insulin (or infused insulin, for insulin pump users). The current landscape includes both long-acting and short-acting insulin analogs, which can be used to design an optimum insulin regimen that takes into account both mealtime and background (basal) insulin needs. Long-acting basal insulin is typically injected once daily, while short- or rapid-acting insulin is typically taken around mealtimes.
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Promising insulin innovations on the horizon
But new forms of insulin, currently under development, could change the way many people with diabetes take insulin. Taking basal insulin once a week, instead of every day, could help many people stick to their insulin regimen with less disruption along the way. Oral insulin could allow some people to avoid injections entirely, and glucose-sensitive insulin could drastically simplify insulin dosing while improving blood glucose control and reducing the risk for hypoglycemia (low blood glucose).
As part of the panel, Harpreet S. Bajaj, MD, medical director of research at LMC Healthcare in Toronto, Canada, noted that two different new weekly insulin formulations — basal insulin Fc (BIF) and insulin icodec — are now in phase 3 clinical trials, typically the final step before a drug is approved (or rejected). These trials are expected to be completed as early as this year for insulin icodec, and in 2024 for BIF.
Previous results from phase 2 trials, Bajaj said, were promising for both BIF insulin icodec. One study showed that for people who also took at least one oral diabetes drug, switching from daily basal insulin to weekly insulin icodec resulted in good blood glucose control, and the switch was well tolerated. Another study showed that in people who previously took an oral diabetes drug and daily basal insulin, taking BIF resulted in just as good blood glucose control as taking insulin icodec, as shown by A1C (a measure of long-term blood glucose control) after 32 weeks.
George Grunberger, MD, a clinical professor of internal medicine and molecular medicine and genetics at Wayne State University School of Medicine in Detroit, discussed a few oral insulin pills that are currently being developed. One type of oral insulin capsule, known as ORMD-801, was shown in phase 2 clinical trials to lead to significantly reduced A1C levels when added to the oral diabetes drug regimens of people who didn’t have adequate blood glucose control.
While it’s too early to know if oral insulin pills will become a mainstay of diabetes treatment, said Grunberger, results from phase 3 clinical trial over the next year will help provide answers about the promise of these potential treatments.
Glucose-sensitive insulin is further behind in the research pipeline, according to Michael A. Weiss, MD, PhD, chair of biochemistry and molecular biology at the Indiana University School of Medicine in Indianapolis. But a so-called “smart insulin” — which would be activated by a tiny synthetic “switch” that releases insulin in response to glucose levels — could completely reshape the insulin landscape if it is shown to be safe and effective.
Right now, said Weiss, the biggest barrier to effective use of insulin — at least for people with type 1 diabetes — is the need to avoid taking too much insulin, which can cause hypoglycemia. If this danger were eliminated, insulin dosing could become far more simplified, since there would no longer be a need to balance “enough” with “too much.” A lot more research is needed before any viable product is developed, but Weiss estimated that the first glucose-sensitive insulins could be available within five years.
Want to learn more about insulin? Read “What Does Insulin Do?,” “Insulin Basics,” and “Everything You Ever Wanted to Know About Injecting Insulin.”