Denosumab for Type 1 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
City of Hope Medical Center
Study ID
NCT06524960
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — OTHER
    Placebo is 1 mL of normal saline drawn up in a commercially available syringe.

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Jul 2025
Primary completion
Oct 11, 2027
Completion
Oct 11, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Denosumab
    Denosumab 60 mg subcutaneous injection
  • Placebo Comparator: Placebo
    Normal Saline 1.0 ml subcutaneous injection

Primary Outcome Measure

Primary safety endpoint [ Time Frame: up to 12 months ]

Central Contacts

  • Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope
    1-866-44-ISLET(1-866-444-7538)
    [email protected]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Tiffany Grimes
[email protected]
205-996-4777
Julia Smith
[email protected]
205-224-7582
Anath Shalev, MD (PRINCIPAL_INVESTIGATOR)
City of Hope Medical CenterDuarteCalifornia91010
Fouad Kandeel, MD, PhD
[email protected]
866-444-7538
Fouad Kandeel, MD, PhD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Hannah Lease
[email protected]
317-278-2538
Carmella Evans-Molina, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope Medical Center· Duarte, CAIndiana University· Indianapolis, IN

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