Welcome to our website for the GLADIATOR clinical research study.
GLADIATOR
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mG twice a day oral LADarixin in patients with recent onset type 1 dIAbeTes and a lOw Residual ß-cell function at baseline.
The GLADIATOR study is now enrolling adolescents and adults ages 14 to 45 with type 1 diabetes. Patients must be currently or have been previously treated with insulin, with the first dose of insulin less than 180 days before enrollment.
To learn about participating or to see if there is a research study center near you, scroll down or click on the page links.
To see if you or your adolescent child may be able to participate and to get a direct contact of the doctor/s closest to you who are conducting the study, please complete the questionnaire on this website.
The GLADIATOR study is sponsored by and this website is owned by Dompé farmaceutici S.p.A., which is the Data Controller under applicable EU law.
Why is this Clinical Research Study Important?
In people with type 1 diabetes (T1D), the immune system mistakenly attacks cells that produce insulin. These cells are called ß-cells, or “beta cells.” [Atkinson, 2014; Waldron-Lynch, 2011] People with T1D who still have some beta cell function tend to have less frequent low blood sugar episodes, a lower rate of microvascular (tiny blood vessels) problems, and generally fewer complications from their disease. Therefore, finding ways to extend or protect beta cell function could potentially be impactful clinical approach to T1D. [Steffes, 2003; Barnard, 2010; Waldron-Lynch, 2011] Ladarixin, an investigational medication, is being evaluated in this clinical study to determine if it may protect beta cell function by decreasing inflammatory destruction and therefore potentially delay the progression of T1D.
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 important that research studies are conducted that may help find new medications for T1D. Before new medications can be approved, they must be evaluated in research studies like this one.
For more in-depth scientific information about the GLADIATOR Study visit
https://clinicaltrials.gov/ct2/show/NCT04628481.
What is Clinical Research?
Although there are several definitions, a clinical research study is considered to be medical research in people with a specific condition using a pre-defined written protocol. Studies like the GLADIATOR study evaluate “investigational” medications, meaning that the medications are not yet approved by medical authorities (such as the FDA in the US, Health Canada in Canada, and EMA in the EU). While in clinical research studies, patients are monitored closely and usually have more contact with their study doctor than would be the case in standard healthcare.
