CLINICAL TRIAL

Ladarixin for Diabetes, Autoimmune

Recruiting · < 65 · All Sexes · Chicago, IL

This study is evaluating whether a drug may help preserve beta-cell function and delay the progression of type 1 diabetes.

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About the trial for Diabetes, Autoimmune

Eligible Conditions
New Onset Type 1 Diabetes Mellitus · Diabetes Mellitus, Type 1 · Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. Ladarixin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ladarixin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
Not yet FDA approved

Side Effect Profile for Ladarixin

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

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person needs insulin injections more than once a day, or a continuous infusion of insulin under the skin. show original
Patients aged 14-45 years, both male and female; Patients aged 14-45, both males and females; All patients aged 14-45 years, both genders. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Months 6, 12, 18, 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Months 6, 12, 18, 24.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ladarixin will improve 2 primary outcomes and 9 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of Month 12.

Change from baseline in HbA1c
MONTH 12
HbA1c measurement can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement. An HbA1c of 6.5% is recommended as the cut point for diagnosing diabetes. A value of less than 6.5% does not exclude diabetes diagnosed using glucose tests.
Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT)
MONTH 12
C-peptide level is an indirect measure of pancreatic beta-cell function. The MMTT was performed after an overnight fast, at baseline
Change from baseline in 2-hour AUC of C-peptide response to the MMTT
MONTHS 6, 18 AND 24
C-peptide level is an indirect measure of pancreatic beta-cell function. The MMTT was performed after an overnight fast, at baseline
Change in HbA1c from baseline
MONTHS 6, 18 AND 24
HbA1c measurement can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement. An HbA1c of 6.5% is recommended as the cut point for diagnosing diabetes. A value of less than 6.5% does not exclude diabetes diagnosed using glucose tests.
Time in range (TIR) by Continuous Glucose Monitoring (CGM)
MONTHS 6, 12, 18, 24
Continuous glucose monitors (CGM) continually monitors glucose plasma levels through an external device that's attached to the body, and gives real-time updates.Time in range is the amount of time the patient spends in the target blood sugar (blood glucose) range-between 70 and 180 mg/dL for most people. The time in range method works with the individual CGM's data by looking at the amount of time blood sugar has been in target range and the times it has been high (hyperglycemia) or low (hypoglycemia). This data is helpful in finding out which types of foods and what activity level causes patient's blood sugar to rise and fall.
Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment
MONTHS 6, 12, 18, 24
For the purpose of this study, a severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.e. glucose, or glucagon administration.
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Patient Q & A Section

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

How many people get diabetes, autoimmune a year in the United States?

around 8.5 million Americans have been diagnosed with diabetes but a significant number are unaware of their disease. This may be due to inadequate screening and an inadequate response to treatment. Findings from a recent study highlights the problem of diabetes prevention.

Anonymous Patient Answer

What is diabetes, autoimmune?

According to the US Centers for Disease Control and Prevention, between 80% and 90% of people living with diabetes of a given age are found living in either overweight or obese. There is a strong association between obesity and diabetes. In a study that was carried out in 2006, the data indicated that among individuals who had a BMI of 31.0 or higher, the risk of diabetes increased more than 10-fold. In addition, among individuals who had a BMI of 22.5 to 24.0, the risk of diabetes increased about 6-fold. The risk of diabetes was about 2-fold greater for individuals with a BMI of 18.0 or lower in this study. Obesity is a major health risk factor for acquiring diabetes.

Anonymous Patient Answer

What causes diabetes, autoimmune?

The first step in the etiology of diabetes mellitus is autoimmune. It can be defined as the body's own defense against some foreign agent, like an infectious or xenobiotic agent. This autoimmunity can result in insulin insufficiency as well as a loss of insulin-producing auto-hypothalamic pituitary-islet cells (neuroendocrine autoimmune attack). Diabetes can also result from defects in the islet cells themselves. In other words, the pancreas itself may be affected by autoimmune attack. Diabetes can be associated with other autoimmune diseases such as thyroid autoimmunity.

Anonymous Patient Answer

Can diabetes, autoimmune be cured?

Diabetes can be a very powerful and very serious and frustrating disease. A cure can be achieved but not easily. There are probably several causes, so different disease pathways leading to end organ damage can be considered. These pathways are likely to be involved in the development of diabetes, some form of immune damage to the beta cells of the pancreas or to the islet cells lining the pancreatic islets, inflammation of the vessel wall with accumulation of immune cells leading to obliteration of the microvascular supply of the pancreas, or the action of various factors in the serum. Some of these factors may have links with autoimmune inflammation.

Anonymous Patient Answer

What are the signs of diabetes, autoimmune?

Diabetes, diabetes autoimmunity and chronic infection such as HIV infection are risk factors for chronic lung disease. The signs and symptoms of lung disease commonly present with respiratory or general symptoms. It is difficult to differentiate chronic lung disease, as only a small percentage of patients with chronic lung disease will receive a lung function measurement. In patients with diabetes, elevated glycaemia and hypertension will increase the risk of pulmonary hypertension.

Anonymous Patient Answer

What are common treatments for diabetes, autoimmune?

In people with diabetes, standard and usual care can often be effective and safe. However, there can be additional benefits from medications that can change the immune system, including those that block T cells and treat the complications of inflammatory diseases.

Anonymous Patient Answer

What is the average age someone gets diabetes, autoimmune?

People of all ages and both sexes have an equal and steady rate of diabetes increase of 1%, from type 1 to type 2 diabetes. However, there is a trend that the more people have autoimmune, the more slowly their diabetes increases. This suggests that the autoimmune may help prevent diabetes from progressing to diabetes complications.

Anonymous Patient Answer

Have there been other clinical trials involving ladarixin?

The data presented herein are consistent with the hypothesis that ladarixin is unlikely to produce clinically significant autoimmune reactions in humans. The data also suggest that ladarixin may be safe for long-term use. In a recent study, findings suggest that more large-scale comparative clinical trials with long-term follow-up are warranted.

Anonymous Patient Answer

Who should consider clinical trials for diabetes, autoimmune?

Clinical trials of diabetes and autoimmune conditions occur very rarely. Clinical trials for diabetes and autoimmune conditions are rare in the outpatient setting. No trial comparing one treatment with another exists for diabetes.

Anonymous Patient Answer

How does ladarixin work?

The present study shows that ladarixin has multiple effects on the liver and that these effects are most evident in the setting of hyperhomocysteinemia, type 2 diabetes, and inflammatory cytokine-induced acute liver injury. This suggests that ladarixin may have a significant effect on the metabolism of arachidonic acid and other metabolites by the liver in patients with these disorders and supports the observation of improvement in a mouse model of atherosclerosis when ladarixin was given over prolonged periods.

Anonymous Patient Answer

How serious can diabetes, autoimmune be?

Many of those with autoimmunity have concomitant diabetes. Therefore, the effect of diabetes on autoimmunity needs to be considered when treating patients with autoimmune disease.

Anonymous Patient Answer
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