NCT05018585

A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Diamyd Medical AB · Industry
• Sex: All
• Age: 12 Years – 28 Years
• Healthy volunteers: Not accepted

Summary

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Detailed description

The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients will have the HLA genotyping performed at the first Screening visit (Visit 1A). If the results indicate the patient is carrying the HLA DR3-DQ2 haplotype, then the patient will attend the second Screening visit (Visit 1B) to perform the remaining screening procedures. Eligible patients will receive injections of Diamyd (also known as retogatein) or placebo into an inguinal lymph gland at three occasions, with one month intervals along with oral Vitamin D supplementation. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. Patients will be followed in a blinded manner for a total of 24 months.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®	Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
DIETARY_SUPPLEMENT	Colecalciferol 2000 IU	Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
BIOLOGICAL	Placebo	Placebo for Diamyd, Alhydrogel® only

Timeline

• Start date: 2022-05-19
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-08-24
• Last updated: 2026-04-15

Locations

60 sites across 9 countries: United States, Czechia, Estonia, Germany, Hungary, Netherlands, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study