Ladarixin for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Università Campus Bio-Medico di Roma (UCBM) Policlinico Universitario, Rome, Italy
Type 1 Diabetes Mellitus+2 More
Ladarixin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Primary objective: To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives: To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. Exploratory objectives (if site is able and deems appropriate to accommodate and conduct these objectives): To determine the effects on insulin sensitivity and circulating markers of inflammation (leukocytes and inflammatory cytokines). Glycemic variability by additional CGM parameters. eGDR and BMI assessments.

Eligible Conditions

  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type 1 Diabetes Mellitus

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: at week 27/28 (visit 4)

Week 26
Incidence of Treatment Emergent Adverse Events (TEAEs) recorded from the beginning of study treatment to up to the end of study participation
Week 11
The proportion of responders at week 11/12 (visit 3)
Week 11
Average (previous 3 days) daily insulin requirements (IU/kg/day) assessed at week 11/12 (visit 3) and 27/28 (visit 4)
Glycemic Variability by CGM (previous 7 days): time in range (TIR), time above range (TAR) time below range (TBR), standard deviation and coefficient of variation assessed at week 11/12 (visit 3) and 27/28 (visit 4)
Week 27
The proportion of responders at week 27/28 (visit 4), with responders defined as "patients with an HbA1c reduction from baseline of ≥0.50% (absolute difference) without episodes of severe hypoglycemia
Week 11
The mean difference from baseline in HbA1c [Timeframe: week 11/12 (visit 3) and 27/28 (visit 4)]

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Type 1 Diabetes Mellitus

Side Effects for

Ladarixin
28%Headache
26%Viral upper respiratory tract infection
12%Pyrexia
12%Dyspepsia
8%Oropharyngeal pain
8%Hypoglycaemia
6%Upper respiratory tract infection
6%Abdominal pain upper
6%Dizziness
6%Nausea
6%Arthralgia
4%Urinary tract infection
4%Diarrhoea
4%Constipation
4%Insomnia
4%Aspartate aminotransferase increased
4%Vomiting
4%Tooth extraction
4%Hyperchlorhydria
4%Dysmenorrhoea
4%Emotional distress
4%Oral herpes
2%Anaemia
2%Neutropenia
2%Nipple inflammation
2%Gastrointestinal disorder
2%Hyperglycaemia
2%Osteoarthritis
2%Gingivitis
2%Faeces hard
2%Clavicle fracture
2%Glycosylated haemoglobin increased
2%Infected bite
2%Tooth abscess
2%Muscle spasms
2%Abdominal pain
2%Sensation of foreign body
2%Eosinophilia
2%Contusion
2%Hypercholesterolaemia
2%Cough
2%Cystitis
2%Lymphadenopathy
2%Acne
2%Ear infection
2%Tinea pedis
2%Toothache
2%Increased viscosity of upper respiratiory secretion
2%Migrane
2%Back pain
2%Asthma
2%Alopecia
2%Iron deficiency anaemia
2%Myalgia
2%Iron deficiency
2%Depression
2%Pancreatitis chronic
2%Muscle injury
2%abdominal discomfort
2%Pharyngitis
2%Alcohol poisoning
2%Dysphagia
2%Gastroenteritis
2%Ear discomfort
2%mental disorder
2%Asthenia
2%Tonsillitis
2%Joint injury
2%Gastroeteritis viral
2%Ligament sprain
2%Syncope
2%Ear pain
2%Dental caries
2%Odynophagia
2%Folliculitis
2%Fatigue
2%Viral infection
2%Gatroesophageal reflux disease
2%Laryngitis
2%Eye infection
2%Alanine aminotransferase increased
2%Skin wound
2%Drug hypersensitivity
2%Fall
0%Sinusitis
0%Vocal cord inflammation
0%Hypertension
0%Blood iron decreased
0%Vitamin D decreased
0%Blood bilirubin increased
0%Rash
0%Hypersensitivity
0%Lymphocytosis
0%Malaise
0%Breast pain
0%Polyuria
0%Haemoglobin increased
0%Bronchitis
0%Laceration
0%Eosinophil count decreased
0%Polycythaemia
0%Weight increased
0%Hyperbilirubinaemia
0%Palpitations
0%Diabetes mellitus management
0%Influenza
0%Sunburn
0%Pain in extremity
0%Injection site reaction
0%Limb injury
0%C-reactive protein increased
0%Anaphylactic reaction
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02814838) in the Ladarixin ARM group. Side effects include: Headache with 28%, Viral upper respiratory tract infection with 26%, Pyrexia with 12%, Dyspepsia with 12%, Oropharyngeal pain with 8%.

Trial Design

2 Treatment Groups

Ladarixin
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

86 Total Participants · 2 Treatment Groups

Primary Treatment: Ladarixin · Has Placebo Group · Phase 2

Ladarixin
Drug
Experimental Group · 1 Intervention: Ladarixin · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
2016
Completed Phase 2
~120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 27/28 (visit 4)
Closest Location: Institute of Cellular Therapeutics · Pittsburgh, PA
Photo of Pittsburgh  1Photo of Pittsburgh  2Photo of Pittsburgh  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Type 1 Diabetes Mellitus
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 21 years of age or older.
You have a duration of T1D of at least 1 year.
You have detectable fasting C-peptide (≥ 0.
You have a continuous glucose monitoring system that can record glucose concentrations continuously for at least 7 days.
You are able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations, and willing to be contacted by clinical trial staff.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.