RecruitingPhase 1Phase 2NCT06524960

Denosumab for Type 1 Diabetes

A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes

Sponsor

City of Hope Medical Center

Enrollment

45 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether denosumab — a drug normally used to strengthen bones — can help preserve insulin-producing cells (beta cells) in people who have recently been diagnosed with type 1 diabetes. In type 1 diabetes, the immune system attacks these cells; denosumab may help protect them and improve blood sugar control over time. **You may be eligible if...** - You are between 21–50 years old (men) or 18–50 years old (women) - You have been diagnosed with type 1 diabetes (T1D) within the past 1–5 years - You have at least one positive diabetes-related autoantibody (such as GADA, IA-2A, or ZNT8A) - Your body still produces some insulin (confirmed by a special test called a mixed meal tolerance test) - Your blood calcium levels are normal - Your HbA1c is 9.5% or below **You may NOT be eligible if...** - You have a history of delayed puberty without confirmed skeletal maturity - You have a vitamin D deficiency - You have an eating disorder or a BMI above 32 - You have had severe low blood sugar or diabetic ketoacidosis in the past 3 months - You are using diabetes medications other than insulin - You have had recent bone fractures or conditions affecting bone health - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDenosumab

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.

OTHERPlacebo

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