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Denosumab for Type 1 Diabetes
C
Carmella Evans-Molina, MD
Primary Investigator
Recruiting
18 years - 50 years
All
Phase
1/2
15 participants needed
1 Location
Brief description of study
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 of study
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
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes
-
Age: 18 years - 50 years
-
Gender: All
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
Updated on
20 Feb 2025.
Study ID: PENDO-COH-DENOSUMAB, 23483
Pre-Screener
