Juan Frias, MD, a medical director with the National Research Institute based in Los Angeles, California will present at the Endocrine Society’s annual meeting known as ENDO 2021 that a new once-weekly basal insulin injection demonstrates similar efficacy and safety, as well as lower rate of low blood sugar episodes, as compared with a daily basal insulin injection. This recent study compared an investigational drug called basal insulin Fc (BIF) with insulin degludec, a commercially available long-lasting daily insulin, in patients with type 2 diabetes (T2D). Dr. Frias reports that “These study results demonstrate that BIF has promise as once-weekly basal insulin and could be an advancement in insulin therapy.” Sponsored by Eli Lilly and Company, the 32-week clinical trial involved 399 patients, all with T2D and previous users of basal insulin combined with oral antidiabetic medications. These results evidence possible advancement for this patient community. A reduced number of injections (weekly instead of daily) could improve adherence to insulin therapy, which may lead to improved patient health outcomes. This marked improvement in patient experience could boost the willingness of T2D patients to start insulin therapy when oral medication no longer supports blood glucose control.
Competitive Space Basal Market
The market for global human insulin is controlled essentially by three multinational pharmaceutical companies, including Novo Nordisk A/S (Denmark), Eli Lilly and Company (USA,) and Sanofi (France). Jointly, they control 96% of the market, making this essentially an oligopoly. Novo Nordisk alone controls nearly half of the market for all insulin products on the market worldwide. Note that TrialSite has reported on the implications of this kind of market power. In 2019, after tremendous public pressure, the trio started dropping prices. With oligopolies or situations where a few company exert such market power the typical competition and price correlation in standard economics doesn’t necessarily play out in the very real world of drug pricing. The insulin market has been a real world laboratory showcasing how companies can actually bid up the price despite market pleads for lower prices. Ultimately, political pressure must be asserted if all else fails.
Note that both Lilly and Novo Nordisk are pursuing once-weekly long-acting insulin in their respective pipelines. Of course, Lilly’s investigational product is showcased herein while the global powerhouse from Bagsværrd wrapped up a study (NCT03751657) with their investigational product called LAI287 (Insulin 287) and entered Phase 3 trials per their pipeline.
One challenge patients face is the fact that there are currently no oral insulins on the market. Novo Nordisk at one point introduced an investigational long-acting oral insulin known as I338 but withdrew the effort as doses were too high and production levels necessary made the overall program not commercially viable as reported recently in Healio Endocrinology.
Oramed Pharmaceuticals pursues an oral insulin known as ORMD-0801 for treating T2D patients: this investigational product is now in Phase 3 clinical trials. In fact, the Israel- and New York City-based biotech recently reported that their clinical trial randomized 25% of 675 patients planned for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of T2D. This is one of two concurrent Phase 3 clinical trials authorized by the U.S. Food and Drug Administration (FDA) to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months.
The Phase 3 study (NCT04606576) started in November, 2020 and runs through till September 2022. The study is supported by Orange County, California-based contract research organization (CRO) Integrium.
The Lilly Study
This study (NCT03736785) involved dozens of trial site locations and was conducted from February 2018 to the end of 2020. In the trial, the patients received random assignments to one of three treatment groups: once-weekly injections of BIF at one of two different dosing algorithms (with different goals for fasting blood glucose levels) or the standard once-daily injections of insulin degludec. One fasting glucose target for patients receiving BIF was 140 milligrams per deciliter (mg/dL) or less, and the other was at or below 120 mg/dL. The fasting glucose target for insulin degludec was 100 mg/dL or less.
Compared with insulin degludec, patients taking BIF achieved similar long-term blood glucose control, as measured by hemoglobin A1c, the researchers reported. Study participants had an average A1c of 8.1 percent at the beginning of the study and at the end of the study had an average improvement in A1c of 0.6 percent for BIF and 0.7 percent for insulin degludec, the data showed.
Additionally, BIF use resulted in significantly lower rates of hypoglycemia, or low blood sugar (less than 70 mg/dL). Severe untreated hypoglycemia is a dangerous complication that can cause seizures, loss of consciousness and death. Frias said BIF has “the potential of a flatter and more predictable action than the current daily basal insulins, which may have contributed to the lower rates of hypoglycemia.”
Regarding safety, BIF had a generally comparable adverse event profile to that of insulin degludec, he said.
“Based on our promising data, further research with BIF has been initiated in patients with type 1 diabetes and other type 2 diabetes patient populations,” Frias said.
Importance of Endocrinologists
Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.
The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at http://www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.
National Research Institute
Based in the Los Angeles metropolitan area, National Research Institute is a prominent trial site organization headquartered in Los Angeles with satellite offices in Los Angeles and Orange County.
Juan Frias, MD, National Research Institute
Call to Action: TrialSite will continue to monitor these clinical trials involving type 2 diabetes. If those individuals interested in this topic have questions, feel free to contact us. TrialSite is introducing patient communities as a way to start leveraging the TrialSite Network to empower patients with objective, unbiased information, and access to resources.