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NCT04899271 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT04899271: Clinical Trial Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT04899271 is a Phase 2 study that was terminated before completion, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04899271, a Phase 2 study, was terminated before completion, sponsored by Dompé Farmaceutici S.p.A.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function. The safety of ladarixin in the specific clinical setting was also evaluated.
Primary Outcome
The sample size of the study is calculated on the "proportion of patients with a HbA1c \< 7% and daily insulin requirement \<0.50 IU/Kg/day", a post-hoc composite endpoint derived from data of the phase 2 trial (MEX0114), considering a larger effect size expected from the longer treatment length (one year versus 3 months). The time frame for the primary endpoint has been set at Month 12 (Week 52) in order to evaluate the potential of ladarixin effects on a long-term projection. Please note tha
Interventions
- OTHER Placebo
- DRUG Ladarixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 2 |
Why NCT04899271 stopped before completion
NCT04899271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04899271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04899271 about?
NCT04899271 is a clinical study titled "A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.". The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function. The safety of ladarixin in the specific clinical setting was also evaluated.
What is the current status of trial NCT04899271?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-12-14. Estimated completion is 2023-10-11.
What interventions are being tested in trial NCT04899271?
The interventions under investigation include: Placebo (OTHER), Ladarixin (DRUG).
Who is sponsoring clinical trial NCT04899271?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04899271's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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