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

CE

Carmella Evans-Molina, MD

Principal Investigator

Status: Recruiting Ages: 18 Years - 50 Years Gender: All Genders Phase: 1/2 4 Locations

Brief Description

Researchers at City of Hope (California), University of Alabama at Birmingham, and Indiana University are studying a medication called denosumab as a potential treatment for people with type 1 diabetes. Denosumab, also known as Prolia, is a drug that has been approved by the Food and Drug Administration for bone disease treatment since 2010. This study will test if denosumab is a safe and effective treatment to help people with type 1 diabetes make insulin and improve blood sugar control.

Detailed Description

What is involved?
  • One to two screening visits to determine study eligibility
  • Injection of denosumab or placebo (injection without medication) once every three months for a total of four doses
  • Follow-up visits at the study site every three months for 12 months
  • Compensation will be provided for participation

Eligibility of study

Inclusion Criteria

  • Age: Females 18-50 years; males 21-50 years
  • Diagnosis of type 1 diabetes (T1D) ≥ 12 months but ≤ 5 years
  • Documented history 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)
  • Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy 

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.