Diabetes researchers at the Indiana University School of Medicine are participating in a new clinical trial investigating whether denosumab, a U.S. Food and Drug Administration-approved treatment for osteoporosis and bone tumors, can preserve insulin-producing beta cells and improve blood sugar control in individuals with early-stage Type 1 diabetes.
Type 1 diabetes is an autoimmune disease that causes the body’s immune system to mistakenly attack insulin-producing beta cells in the pancreas. This leads to high blood sugar levels that require daily insulin management and significant lifestyle challenges. The disease progresses through four stages, with early intervention offering the best opportunity to preserve remaining beta cell function.
“Denosumab has been an FDA-approved drug for bone disease treatment since 2010,” said Carmella Evans-Molina, MD, PhD, the trial’s co-principal investigator and director of the Indiana Diabetes Research Center and IU Center for Diabetes and Metabolic Diseases. “Early studies in labs have shown that the same properties that make it effective for bone health may also support beta cell function. The potential of denosumab to protect and preserve beta cell function could represent a significant advancement in managing Type 1 diabetes.”
The clinical study, “Denosumab for Type 1 Diabetes,” will test whether the medication denosumab, also known as Prolia, is safe and effective in improving beta cell function and blood sugar control in people with early Type 1 diabetes.
The multicenter Phase 1/2 clinical trial is a randomized, double-blind and placebo-controlled study, meaning some participants will receive denosumab injections while others receive injections without medication. Researchers are currently enrolling individuals diagnosed with Type 1 diabetes within the last five years. The study is seeking women between 18 and 50 years old and men between 21 and 50 years old who meet the eligibility criteria. Participants will be compensated for their time.
“Participants in this study have an incredible opportunity to contribute to research that could transform the future of Type 1 diabetes treatment,” said Gabriela Scavacini de Freitas Monaco, MD, the clinical trial’s lead coordinator at IU. “We’re excited to get started and see if denosumab can make a real difference for people living with the disease.”
In addition to the IU School of Medicine, the trial is being conducted at City of Hope in Los Angeles and the University of Alabama at Birmingham. Study participants will be followed for 12 months to assess changes in beta cell function and blood sugar control.
For more information, visit the study’s website or contact pedsdiab@iu.edu.
