About this Study
Gladiator: Type 1 Diabetes Study
According to the National Institutes of Health, type 1 diabetes (T1D) occurs when the body’s immune system attacks and destroys ß-cells (“beta cells”) in the pancreas. These beta cells are responsible for producing insulin, which controls blood sugar levels. People with T1D may have some beta cell function left. Maintaining that residual beta cell function has been linked to improved quality of life and fewer complications from T1D. [Steffes, 2003; Barnard, 2010; Waldron-Lynch, 2011]
This is why medical researchers are looking at investigational medications that may preserve beta cell function. Based on preclinical and clinical data, it is hypothesized that ladarixin may inhibit the inflammatory immune process that is thought to destroy beta cell function, and therefore preserve function and improve maintenance of blood sugar levels. Ladarixin is an investigational novel small molecule that inhibits the biological activity of IL-8, a pro-inflammatory mediator involved in beta cell damage during the onset and the progression of the disease.
This research study will evaluate ladarixin effectiveness in preserving beta-cell function and delaying the progression of T1D in adolescent and adult patients. The safety of ladarixin in this clinical setting will also be evaluated. For more in-depth scientific information about the GLADIATOR Study visit
https://clinicaltrials.gov/ct2/show/NCT04628481.
The number of people diagnosed with T1D is increasing and is expected to continue to increase in the future. [Atkinson, 2014; Waldron-Lynch, 2011] This is why it is so important that research studies are conducted that may help find new or better medications to help people with T1D.
If you or your adolescent child has been recently diagnosed with diabetes, please complete the questionnaire have your information evaluated. If you or your child completes the questionnaire and meets the preliminary criteria to participate, you or your child will have access to the contact information of the investigator study center closest to your location allowing you to reach out to the study personnel to discuss your/your child’s condition and to discuss the study in more detail.
The Purpose of this Clinical Research Study
The purpose of this research study is to evaluate the safety and efficacy of ladarixin in preserving beta-cell function which may delay the progression of T1D in adolescent and adult patients.
Ladarixin is an investigational medication in a capsule form that is taken orally twice a day in this study.
Approximately 327 patients are expected to participate in this research study.
What to Expect
The study center staff, if reached out to by those people who are interested in participating in this research study, will talk with them and with their parent/guardian, if under 18 years old. If the study staff think that the person may qualify to participate, they will schedule the potential patient for a screening visit at the study center. At this screening visit, the study requirements as well as the potential risks of participation will first be explained in detail.
People wishing to participate after this explanation will be asked to sign a written consent form before any screening procedures are performed. If under the age of 18, a parent or guardian must sign this consent form on their behalf. In addition to their parent/guardian signing the consent form, adolescent patients must sign an assent form to confirm they understand and agree with what will happen during the research study. No study procedures will take place before the forms are signed.
Those people who sign the consent/assent form will enter the run-in portion of the study, which includes screening and a baseline assessment. During screening and this assessment, the study team will determine whether those wishing to participate in the study satisfy all applicable requirements by performing tests and closely monitoring blood sugar levels.
If fully qualified, patients will begin the 12-month treatment period of the study. Patients will be assigned to receive either ladarixin or a placebo, a capsule that looks like ladarixin but has no active ingredients. The assignment to either ladarixin or placebo is made randomly, and the chance of receiving the placebo is 33%, or 1 out of 3. Neither patients nor study personnel will know which was assigned. “Study Drug” as used in this website will mean the treatment that the patient is assigned to take, which will be either ladarixin or placebo. Patients will record each dose of Study Drug taken during the treatment period in an electronic diary that will be reviewed at study visits.
Study patients will have 2 follow-up visits at about 6 and 12 months after the last dose of Study Drug.
The total duration of participation for those in the study including potential screening time, the treatment period, and the follow-up visit will be between 18 to 24 months.
As showed in previous human studies, the compound (or drug) ladarixin, orally administered as adjunct therapy to insulin, is safe and very well-tolerated with no significant side effects. The study staff will discuss known and unknown risks with patients before any consent/assent documents are signed. During the entire treatment period, patients will be closely monitored for safety.
Participation Costs
All medical examinations, medical devices, and the Study Drug (ladarixin or placebo) are provided to qualified patients at no cost. Financial compensation may also be provided to cover travel and other expenses related to the research study. The amount of available compensation will be discussed with you by the staff at the study center.
