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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%
Insomnia
4%
Tooth extraction
4%
Constipation
4%
Diarrhoea
4%
Hyperchlorhydria
4%
Vomiting
4%
Oral herpes
4%
Urinary tract infection
4%
Aspartate aminotransferase increased
4%
Dysmenorrhoea
2%
Nipple inflammation
2%
Fall
2%
Depression
2%
Alopecia
2%
Ear pain
2%
Muscle injury
2%
Anaemia
2%
Joint injury
2%
Ligament sprain
2%
abdominal discomfort
2%
mental disorder
2%
Ear discomfort
2%
Alanine aminotransferase increased
2%
Syncope
2%
Contusion
2%
Asthma
2%
Skin wound
2%
Neutropenia
2%
Migrane
2%
Iron deficiency anaemia
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
51 Previous Clinical Trials
4,708 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
~6 spots leftby Jun 2025
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