| Trial ID: | L1868 |
| Source ID: | NCT06524960
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| Associated Drug: |
Denosumab
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| Title: |
Denosumab for Type 1 Diabetes
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 1 Diabetes
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| Interventions: |
DRUG: Denosumab|OTHER: Placebo
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| Outcome Measures: |
Primary: Primary safety endpoint, 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. Toxicity: Toxicity and adverse events (except hypoglycemia and DKA) will be recorded in the eCRFs using the NCI CTCAE v 5.0 (See Section 7.0 for specific AEs). Hypoglycemia and DKA events will be defined per Section 14.1.1. - From treatment day through Month 12: All grade toxicities/AEs will be recorded. Safety will be assessed at baseline and at 3, 6, 9 and 12 months., up to 12 months|Primary efficacy endpoint, 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 during MMTT in denosumab group will be compared to placebo group at 12 months from baseline. Change in Beta cell function (baseline and at 12 months) - Mixed meal tolerance test, up to 12 months | Secondary: Beta cell function, 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, Up to 6 months|HbA1c improvement, 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 (%) + \[4 x insulin dose (units/kg/24hr)\]., up to 12 months | Other: Glucose variability, To evaluate the efficacy of denosumab on glucose variability as defined by time in target, and hypoglycemic and hyperglycemic ranges at 6 and 12 months. Glucose variability as defined by percent time in glycemic range (70-180 mg/dl and 70-140 mg/dl) and time spent in hypoglycemic and hyperglycemic ranges from continuous glucose monitoring data in denosumab group will be compared to placebo group. Glucose variability (baseline and at 6 and 12 months) - Continuous glucose monitoring, up to 12 months|Insulin sensitivity, To evaluate the efficacy of denosumab on insulin sensitivity as calculated by the HOMA2 formula at 12 months. Insulin sensitivity as measured by HOMA2 in denosumab group will be compared to placebo group. Insulin sensitivity (baseline and at 12 months), up to 12 months
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| Sponsor/Collaborators: |
Sponsor: City of Hope Medical Center
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1|PHASE2
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| Enrollment: |
45
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2024-09-03
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| Completion Date: |
2026-04-11
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| Results First Posted: |
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| Last Update Posted: |
2024-12-05
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| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|City of Hope Medical Center, Duarte, California, 91010, United States|Indiana University, Indianapolis, Indiana, 46202, United States
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| URL: |
https://clinicaltrials.gov/show/NCT06524960
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