A new phase 1/2 clinical trial, led by City of Hope, is investigating whether an osteoporosis medication could play a role in enhancing beta cell function in individuals with early-stage type 1 diabetes. The trial aims to determine if denosumab, a human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for treating osteoporosis and bone tumors, can protect and regenerate the beta cells responsible for insulin production.
Type 1 diabetes is an autoimmune condition where the immune system destroys the beta cells in the pancreas, leading to insufficient insulin production. However, in the early stages of the disease, some beta cells may still remain functional.
The randomized, double-blind, multicenter study will evaluate the safety and effectiveness of denosumab in improving beta cell function and managing blood sugar levels in patients who continue to produce some insulin. This research represents an innovative approach, potentially expanding or protecting the remaining beta cells in early-stage type 1 diabetes patients.
“We are thrilled about this novel use of denosumab, which could not only help preserve beta cell function but also potentially benefit other diabetes patients by enhancing beta cell regeneration,” said Dr. Fouad R. Kandeel, co-principal investigator of the study and distinguished chair in Diabetes & Metabolism Research at City of Hope.
Denosumab works by inhibiting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a protein that damages bone. Researchers at City of Hope have discovered that this same pathway may contribute to the destruction of beta cells. Previous studies have shown that denosumab could block this harmful effect, offering protection and potentially increasing the number and functionality of beta cells in the pancreas.
The goal of the trial is to slow the progression of type 1 diabetes by maintaining beta cell function, ultimately improving blood sugar control for patients.
This clinical trial is funded primarily by Breakthrough T1D (formerly JDRF), the global leader in type 1 diabetes research and advocacy. Additionally, the study is supported by The Wanek Family Project for Type 1 Diabetes at City of Hope.
The trial is currently recruiting participants in the Los Angeles area, as well as at the University of Alabama at Birmingham and Indiana University. Eligible participants must be adults aged 18 to 50, diagnosed with type 1 diabetes within the past five years, and still producing some insulin. The study will administer denosumab in a regimen of four injections over 12 months, with a treatment group of 30 individuals and a placebo group of 15 participants. The results will be monitored to assess changes in beta cell function and blood sugar control.
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