Ladarixin for Diabetes, Autoimmune
This study is evaluating whether a drug may help preserve beta-cell function and delay the progression of type 1 diabetes.
See full descriptionAbout the trial for Diabetes, Autoimmune
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.
About The Treatment
Side Effect Profile for Ladarixin
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.