Researchers have launched a phase 1/2 clinical trial to see if osteoporosis medication can enhance beta cell health among people living with early type 1 diabetes.
During the trial, scientists from City of Hope® will assess if people with early type 1 diabetes can protect and preserve their beta cells by using denosumab – a human monoclonal antibody that is used to treat osteoporosis and bone tumours.
Typically, type 1 diabetes destroys beta cells, but in the early stages of the disease, some of these cells can still function
This randomised, double-blind, multicentre clinical trial will also analyse if denosumab improves blood sugar control among people with early type 1 diabetes.
First author Dr Fouad R Kandeel said: “This is an exciting new application of a known medication that, in addition to potentially protecting and/or expanding the beta cells that remain in early type 1 diabetes people, might also be able to help other people with diabetes to increase beta cell number and/or function.
“We are actively working to enrol qualified patients and look forward to seeing where this trial leads us.”
Denosumab prevents bone damage by inhibiting a protein called RANKL and stopping it from interacting with the receptor RANK.
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Joint author Professor Rupangi Vasavada said: “We have found that the same RANKL/RANK pathway can destroy beta cells.
“Previous studies have shown that denosumab can inhibit this detrimental pathway and improve beta cell health by protecting, increasing the number and/or improving the function of beta cells.”
This osteoporosis medication could slow down the progression of type 1 diabetes and enhance blood sugar control by protecting and preserving beta cell function.
Breakthrough T1D has predominantly funded this trial, alongside The Wanek Family Project for Type 1 Diabetes at City of Hope®.
Recruitment for the trial is now underway at City of Hope® in the Los Angeles area. In addition, recruitment is taking place at the University of Alabama at Birmingham and Indiana University.
To take part, you must be aged between 18 and 50, and living with early type 1 diabetes, meaning you were diagnosed with the condition less than five years ago.
A total of 30 adults will receive the denosumab regimen of 60 milligrams injection given under the skin every three months for a total of four injections.
Meanwhile, a total of 15 adults are needed for the placebo arm of the study, with these participants receiving normal saline placebo using the same regimen.
