Denosumab for Type 1 Diabetes

Phase 1

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Drug: Denosumab; Other: Placebo

• Registration Number: NCT06524960
• Lead Sponsor: City of Hope Medical Center

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 th...

Detailed Description

This is a Phase 1/2, 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 t...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Study Start: 2024-09-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-04-11
• Study Completion: 2026-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	Denosumab 60 mg subcutaneous injection
Placebo	Placebo	Normal Saline 1.0 ml subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint	up to 12 months	To evaluate the efficacy of denosumab in improving beta cell function in T1D subjects as measured by difference of mean area under the curve (AUC) of plasma C-peptide during 2-hr mixed meal tolerance test (MMTT) at baseline and 12 months after initiation of treatment (primary efficacy endpoint). Beta cell function as determined by the change in C-peptide AUC...
Primary safety endpoint	up to 12 months	To evaluate the safety of denosumab as assessed by the occurrence of adverse events (primary safety endpoint). Occurrence of treatment-related adverse events in denosumab group compared to placebo group during the 12 months.; ...

Secondary Outcome Measures

Name	Time	Method
HbA1c improvement	up to 12 months	To evaluate the efficacy of denosumab in improving HbA1c and insulin-dose adjusted HbA1c (IDAAIC) at 12 months. Changes in HbA1c and IDAAIC in denosumab group compared to placebo group.; Glycemic Control (baseline and at 3, 6, 9 and 12 months); * HbA1c; * IDAAIC is calculated as HbA1c (%) + \[4 x insulin dose (units/kg/24hr)\].
Beta cell function	Up to 6 months	To evaluate the efficacy of denosumab in improving beta cell function as measured by C-peptide AUC during MMTT at 6 months. Beta cell function as determined by C-peptide AUC during MMTT in denosumab group will be compared to placebo group at 6 months.; Beta cell function (baseline and at 6 months); - Mixed meal tolerance test

Trial Locations

Locations (3)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States