Denosumab for Type 1 Diabetes
Sponsor: City of Hope Medical Center • ClinicalTrials.gov ID: NCT06524960
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Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D.
Interventions
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Denosumab
(Drug)
Denosumab is a sterile, preservative-free, clear, colorless to pale yellow solution. Each 1 mL single-dose prefilled syringe of denosumab contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, 0.01% polysorbate 20, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
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Placebo
(Other)
Placebo is 1 mL of normal saline drawn up in a commercially available syringe.
Eligibility criteria
Conditions
Locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- City of Hope Medical Center — Duarte, California, United States
- Indiana University — Indianapolis, Indiana, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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