Denosumab is a monoclonal antibody, which is already approved for several bone related diseases and is sold under the names Wyost, Xgeva, Prolia, and Jubbonti. A research team has found that the pathway that Denosumab targets also has effects on beta cells. Animal studies suggest that Denosumab may protect and/or increase the number of beta cells and improve how well they work. It was first approved in 2010 after being developed by Amgen. There is a biosimilar available from Sandoz.
Denosumab is a subcutaneous (under the skin) injection, much like insulin. It is taken every month or every six months, depending on the bone disease being treated.
This Study
This is a phase-I trial in 45 adults who have had T1D for between 1 and 5 years. It is blinded, randomized and has a control group. People will get one injection every 3 months for one year.
There are two primary end points. For safety, they will track adverse events and for effectiveness they will measure C-Peptide levels. There are secondary end points for more C-Peptide measures and also for A1c measurements. There are tertiary end points for time-in-range and insulin sensitivity.
The trial started in September 2024 and should run until April 2026.
This study is funded by JDRF and is run out of City Of Hope. Contact information is:
Name: Arthur Riggs Diabetes & Metabolism Research Institute at COH
Phone: 1-866-44-ISLET(1-866-444-7538)
Email: Islets@coh.org
And the three sites recruiting are:
University of Alabama-Birmingham Comprehensive Cancer Center
Anath Shalev, MD
205-996-4777 ashalev@uabmc.edu
City of Hope Medical Center, Duarte, California, United States, 91010
Fouad Kandeel, MD, PhD
866-444-7538 Islets@coh.org
Indiana Univ Med Ctr, Indianapolis, Indiana, United States, 46202
Carmella Evans-Molina, MD
317-278-3177 cevansmo@iu.edu
Discussion
This study is being done on people with established T1D, not honeymooners. However, I'm not sure why. The researchers state specifically that "Lab studies suggest that Denosumab may protect and/or increase the number of beta cells and improve how well they work." For me, that suggests that this treatment would work much better during the honeymoon, when people with T1D still have some beta cells that work. It is a mystery to me why they chose established T1Ds rather than honeymooners.
One large population based study, done in Taiwan, showed that people using Denosumab for Osteoporosis had a significantly smaller chance of being diagnosed with type-2 diabetes, than those who where not taking the drug. That is an interesting finding, but those people all had plenty of working beta cells, so it is not clear to me that this finding is useful for people with established type-1 diabetes. That study is published here: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2814873
If this treatment is found effective, it could be used off label immediately, without FDA approval, since it is already approved for a different disease.
Denosumab: https://medlineplus.gov/druginfo/meds/a610023.html
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
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