Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524960
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Denosumab for Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
Detailed Description:
This is a Phase 12 prospective randomized double-blind placebo-controlled multi-center clinical trial to evaluate the safety and efficacy of denosumab for improving beta cell function and glycemic control among patients with early T1D and detectable C-peptide The efficacy of denosumab will be evaluated by changes in C-peptide level during mixed meal tolerance test and achieving a clinically meaningful HbA1c reduction at 12 months Subjects will be followed for 12 months for adverse events and for changes in beta cell function and glycemic control parameters
Subjects will be randomized with a 21 treatment to placebo ratio The treatment group will enroll 30 subjects with the denosumab regimen of 60 mg given subcutaneously every 3 months for a total of 4 injections The placebo arm will enroll 15 subjects and be administered with normal saline placebo given subcutaneously every 3 months for a total of 4 doses
Subjects will be randomized with a 21 treatment to placebo ratio The treatment group will enroll 30 subjects with the denosumab regimen of 60 mg given subcutaneously every 3 months for a total of 4 injections The placebo arm will enroll 15 subjects and be administered with normal saline placebo given subcutaneously every 3 months for a total of 4 doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None