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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

NCT05018585 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

  • Diamyd Medical AB

    lead INDUSTRY

Principal Investigators

  • Johnny Ludvigsson, Professor · Crown Princess Victoria Children´s Hospital and Linköping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018585 on ClinicalTrials.gov