Can a Twice-Daily Pill Delay Progression of Type 1 Diabetes?

A U.S. clinical trial is recruiting adolescents and adults between the ages of 14 and 45 with recently diagnosed type 1 diabetes to evaluate the effectiveness of ladarixin, a treatment that may preserve beta-cell function and delay the progression of type 1 diabetes. The study will also evaluate the drug’s safety.

Clinical Trials Identifier: NCT04628481

Trial Name: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

Diabetes Type: Teens and adults with type 1 diabetes

Trial Sponsor: Dompé Farmaceutici S.p.A

What is the trial testing?

This trial aims to evaluate whether ladarixin, a twice-daily oral pill, is effective in slowing down the progression of type 1 diabetes by preserving beta-cell function. Teens and adults diagnosed with type 1 diabetes within the last 6 months will be randomly assigned 2-to-1 to receive either ladarixin 400 mg twice a day (for 13 cycles of 14 days on the pill, 14 days off) or placebo.

The primary goal of this study is to see if there are any changes in the function of beta cells by measuring C-peptide levels (an indirect measure of pancreatic beta-cell function). The researchers will also observe any changes in A1C, time in range, and daily insulin requirements.

Why is this trial new and important?

Type 1 diabetes remains a chronic condition in which the beta cells of the pancreas (the cells that produce insulin) are destroyed by the body’s immune system. Although there is currently no way to prevent type 1 diabetes, a treatment that can protect and preserve remaining beta-cell function would be valuable.

Trial Length: 18 months

Trial Locations: This is a multicenter, international study with 62 locations across the United States and Europe. Click here to see a list of all participating locations.

Are you interested?

You or your child may be eligible to participate in this trial if you:

• Were diagnosed with type 1 diabetes within the last 6 months 

• Have tested positive for at least one diabetes-related auto-antibody

• Require, or have required at some time, insulin injections

• Are 14 to 45 years old

See a full list of inclusion/exclusion criteria here.

For more information: Please contact Maria De Pizzol at +3902583831 or clinops@pec.dompe.it. 

About the authors

Eugenia Yun

Eugenia Yun is an award-winning health and science editor with over 15 years of experience covering medical news in 30+ specialty areas for both healthcare professionals and general readers. She... Read the full bio »