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CXC Chemokine Receptor Antagonist

Ladarixin for Type 1 Diabetes

Phase 2
Waitlist Available
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 12 and 18
Awards & highlights

Study Summary

This trial is testing a new drug to see if it helps improve glycemic control in newly diagnosed adult patients with Type 1 diabetes who still have some beta cell function.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 6, 12 and 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6, 12 and 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with HbA1c <7% and daily insulin requirement <0.50 IU/Kg/day
Secondary outcome measures
2-hour AUC of C-peptide response to the MMTT
Additional Glucose Variability Indices derived from CGM: CONGA-n
Additional Glucose Variability Indices derived from CGM: MAGE
+13 more

Side effects data

From 2019 Phase 2 trial • 76 Patients • NCT02814838
28%
Headache
26%
Viral upper respiratory tract infection
12%
Dyspepsia
12%
Pyrexia
8%
Hypoglycaemia
8%
Oropharyngeal pain
6%
Arthralgia
6%
Abdominal pain upper
6%
Nausea
6%
Dizziness
6%
Upper respiratory tract infection
4%
Emotional distress
4%
Tooth extraction
4%
Insomnia
4%
Constipation
4%
Diarrhoea
4%
Hyperchlorhydria
4%
Vomiting
4%
Oral herpes
4%
Urinary tract infection
4%
Aspartate aminotransferase increased
4%
Dysmenorrhoea
2%
Fall
2%
Alopecia
2%
Asthma
2%
Iron deficiency anaemia
2%
Muscle injury
2%
Skin wound
2%
Ear pain
2%
Alanine aminotransferase increased
2%
Nipple inflammation
2%
Depression
2%
mental disorder
2%
Ear discomfort
2%
Contusion
2%
Syncope
2%
Anaemia
2%
abdominal discomfort
2%
Joint injury
2%
Ligament sprain
2%
Neutropenia
2%
Migrane
2%
Glycosylated haemoglobin increased
2%
Hyperglycaemia
2%
Drug hypersensitivity
2%
Acne
2%
Abdominal pain
2%
Eosinophilia
2%
Dental caries
2%
Gatroesophageal reflux disease
2%
Folliculitis
2%
Hypercholesterolaemia
2%
Back pain
2%
Lymphadenopathy
2%
Dysphagia
2%
Faeces hard
2%
Odynophagia
2%
Pancreatitis chronic
2%
Asthenia
2%
Fatigue
2%
Sensation of foreign body
2%
Cystitis
2%
Ear infection
2%
Eye infection
2%
Gastroenteritis
2%
Gastroeteritis viral
2%
Gingivitis
2%
Infected bite
2%
Iron deficiency
2%
Muscle spasms
2%
Myalgia
2%
Osteoarthritis
2%
Toothache
2%
Laryngitis
2%
Pharyngitis
2%
Tinea pedis
2%
Tonsillitis
2%
Tooth abscess
2%
Gastrointestinal disorder
2%
Clavicle fracture
2%
Viral infection
2%
Alcohol poisoning
2%
Cough
2%
Increased viscosity of upper respiratiory secretion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ladarixin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LadarixinExperimental Treatment1 Intervention
The treatment group will receive 400 mg b.i.d. for 13 cycles of 14 days on/14 days off)
Group II: PlaceboPlacebo Group1 Intervention
The control group will receive matched placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
2016
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,509 Total Patients Enrolled
Enrico M Minnella, MDStudy DirectorDompé Farmaceutici
Flavio Mantelli, MDStudy DirectorDompé Farmaceutici
1 Previous Clinical Trials
261 Total Patients Enrolled

Media Library

Ladarixin (CXC Chemokine Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04899271 — Phase 2
Type 1 Diabetes Research Study Groups: Ladarixin, Placebo
Type 1 Diabetes Clinical Trial 2023: Ladarixin Highlights & Side Effects. Trial Name: NCT04899271 — Phase 2
Ladarixin (CXC Chemokine Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899271 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial break new ground?

"Ladarixin is being tested in 2 ongoing trials located across 24 cities and 8 countries. The first trial for Ladarixin was conducted in 2020 by Dompé Farmaceutici S.p.A. That Phase 2 clinical study included 25 participants and completed drug approval in 2020. Since then, 18291 studies have been completed."

Answered by AI

Is this clinical trial taking place in a significant number of hospitals across Canada?

"This clinical trial has 5 enrolling sites which include Global Life Research Network in Miami, Atlanta Diabetes Associates (ADA) in Atlanta, and University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC), among other locations."

Answered by AI

How many people are being given this medication as part of the research project?

"This trial is no longer recruiting patients. It was originally posted on December 14, 2020 and last updated on May 2, 2022. There are presently 1304 clinical trials actively looking for patients with new onset type 1 diabetes mellitus and 2 trials for Ladarixin that are actively recruiting patients."

Answered by AI

Is this trial only meant for elderly patients?

"This trial is only looking for patients aged 18-45. In comparison, there are 226 clinical trials seeking out individuals under the age of 18 and 964 studies searching for elderly participants over the age of 65."

Answered by AI

Who would this trial be applicable to?

"We are looking for 25 men and women aged 18-45 who have recently been diagnosed with type 1 diabetes mellitus. To be eligible, patients must require (or have required at some point) insulin therapy through multiple daily injections or continuous subcutaneous insulin infusion. Lastly, candidates should be able to commit to all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations."

Answered by AI

What is the evidence base for Ladarixin's efficacy?

"Ladarixin was first researched in 2020 by the Joslin Diabetes Center at Harvard Medical School. Out of the 18,291 completed studies, there are only 2 that are actively recruiting participants. Most of these trials are based in Miami, Florida."

Answered by AI

Could you explain the risks associated with taking Ladarixin?

"Because Phase 2 trials only have data supporting safety and no efficacy, our team at Power has given Ladarixin a score of 2."

Answered by AI

Are patients currently being accepted into this trial program?

"The latest information available on clinicaltrials.gov suggests that this trial is not presently recruiting patients, though this could change in the future. This study was initially posted on December 14th, 2020 and was most recently updated on May 2nd, 2022. Although this particular trial isn't looking for patients right now, there are 1306 other studies that are actively enrolling patients across a variety of conditions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.
2020. "A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899271.
~6 spots leftby Apr 2025
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