A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
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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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.
Study identification
- NCT ID
- NCT04628481
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 289 participants
Conditions and interventions
Conditions
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 12, 2021 (Actual)
- Primary completion
- Mar 31, 2025 (Actual)
- Completion
- Oct 21, 2025 (Actual)
- Last update posted
- Aug 31, 2026
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 Aug 31, 2026 · Synced Nov 12, 2026
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