A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
Public ClinicalTrials.gov record NCT04628481. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Effect and Safety of 400 mg Twice a Day Oral Ladarixin in Patients With Recent Onset Type 1 Diabetes and Low Residual β-cell Function at Baseline (GLADIATOR)
Study identification
- NCT ID
- NCT04628481
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Industry
- Enrollment
- 141 participants
Conditions and interventions
Conditions
Interventions
- Ladarixin Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 14 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2021
- Primary completion
- Mar 30, 2025
- Completion
- Oct 20, 2025
- Last update posted
- Dec 16, 2025
2021 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC) | Birmingham | Alabama | 35294 | — |
| Phoenician Centers for Research and Innovation | Phoenix | Arizona | 85021 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| Center of Excellence in Diabetes & Endocrinology (CEDE) | Sacramento | California | 95821-2123 | — |
| University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic | Aurora | Colorado | 80045 | — |
| Christiana Care Endocrinology Specialists | Newark | Delaware | 19713 | — |
| Diabetes Care Center - Hudson | Hudson | Florida | 34667-7151 | — |
| Global Life Research Network | Miami | Florida | 33155 | — |
| AdventHealth (Florida Hospital) - Diabetes Institute - Orlando | Orlando | Florida | 32804 | — |
| Atlanta Diabetes Associates (ADA) | Atlanta | Georgia | 30318 | — |
| The University of Chicago | Chicago | Illinois | 60637 | — |
| Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical | Springfield | Illinois | 62711 | — |
| Indiana University - Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| The Cotton-O'Neil Diabetes and Endocrinology Center | Topeka | Kansas | 66606-28 | — |
| University of Louisville | Louisville | Kentucky | 40292 | — |
| Joslin Diabetes Center, Harvard Medical School | Boston | Massachusetts | 02215 | — |
| UBMD Physicians Group - Pediatrics - Conventus | Buffalo | New York | 14203 | — |
| "WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location" | Raleigh | North Carolina | 27610 | — |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| University of Pittsburgh - UPMC | Pittsburgh | Pennsylvania | 15261 | — |
| Cook Children's Endocrinology and Diabetes Program | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04628481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2025 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04628481 live on ClinicalTrials.gov.