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A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.

NCT04899271 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-05-14

Study results available
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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.

Conditions

  • New-onset Type 1 Diabetes

Interventions

DRUG

Ladarixin

400 mg b.i.d. for 13 cycles of 14 days on/14 days off

OTHER

Placebo

Placebo was administered orally with the same scheme of administration of LDX to preserve blinding

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Enrico M Minnella, MD · Dompé Farmaceutici

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2023-04-27
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Georgia
  • Germany
  • Italy
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04899271 on ClinicalTrials.gov