Skip to main content
Premium Trial:

Request an Annual Quote

Diamyd Medical to Expand Phase III Diabetes Drug Trial to US

NEW YORK – Diamyd Medical on Tuesday said it will expand a registrational Phase III trial of the type 1 diabetes drug, also called Diamyd, into the US.

Stockholm-based Diamyd is preparing to initiate the first US site for the DIAGNODE-3 trial, in which it is assessing the activity of the eponymous antigen-specific immunotherapy in type 1 diabetes patients who carry the HLA DR3-DQ2 haplotype. It expects to kick off at additional US sites in the coming months, aiming to launch between 10 and 12 sites around the country. The trial is already underway at approximately 50 sites in eight European countries. 

Diamyd's immunotherapy contains the active ingredient GAD65, a protein that is targeted by autoantibodies in patients with type 1 diabetes. By administering the drug into the lymph nodes, Diamyd is aiming to slow or halt autoimmune destruction of insulin-producing cells.

In the DIAGNODE-3 trial, investigators are recruiting patients 12 to 29 years of age with recent onset type 1 diabetes. In order to participate in the study, patients must carry the HLA DR3-DQ2 marker, which is associated with response to the treatment. The company said it will further stratify HLA DR3-DQ2 carriers according to whether they are negative for the HLA DR4-DQ8 haplotype to gauge if this biomarker profile captures a "super responder" group.

Researchers in the study are also measuring stimulated C-peptide in patients to see how effectively the investigational treatment preserves endogenous insulin production and tracking HbA1c to gauge the drug's ability to control blood glucose.

Diamyd aims to complete enrolling the Phase III trial in the second half of 2024.