Join Trial Testing Bone Drug for Recently Diagnosed Type 1 Diabetes
This study is recruiting participants to test the effectiveness of denosumab, an approved medicine for osteoporosis, to improve beta cell function and blood sugar management in people with early type 1 diabetes.
Trial status: Recruiting
Clinical Trials Identifier: NCT06524960
Trial Name: Denosumab for Type 1 Diabetes
Diabetes Type: Adults with type 1 diabetes who were diagnosed between 1 and 5 years ago
Trial Sponsor: City of Hope Medical Center
Why is this study important?
This study is investigating the effects of denosumab – an approved medicine used to treat osteoporosis – in people with early type 1 diabetes. If successful, denosumab could help protect beta cells and slow the progression of type 1 diabetes.
How does the trial work?
Participants will be randomly assigned to either the active treatment or placebo group. Those assigned to the treatment group will receive a 60 mg subcutaneous injection of denosumab every three months for a total of four injections. The placebo group will receive a saline injection every three months for a total of four doses.
To determine the safety and effectiveness of denosumab, participants will be followed for 12 months to check for adverse events and measure changes in C-peptide levels during a mixed meal tolerance test, as well as changes in A1C.
Are you interested in participating?
Females between 18-50 years of age, or males between 21-50 years of age, may be eligible to participate if you:
- Have been diagnosed with type 1 diabetes for at least one year but no more than five years
- Have documentation of at least one type 1 diabetes associated autoantibody:
- GAD specific autoantibodies (GADA);
- Islet-antigen 2 specific autoantibody (IA-2A); and/or
- Zinc Transporter 8 specific autoantibody (ZNT8A)
People with a vitamin D3 deficiency, BMI greater than 32, or A1C greater than 9.5% are not eligible to participate in this study. See a full list of inclusion/exclusion criteria here.
This trial is currently recruiting in three locations (Southern California, Indiana and Alabama) across the U.S.
Learn more about type 1 diabetes treatments and trials here: