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
Public ClinicalTrials.gov record NCT05018585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05018585
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 321 participants
Conditions and interventions
Conditions
Interventions
- Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® Biological
- Colecalciferol 2000 IU Dietary Supplement
- Placebo Biological
Biological · Dietary Supplement
Eligibility (public fields only)
- Age range
- 12 Years to 28 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2022
- Primary completion
- Jun 23, 2026
- Completion
- Jun 23, 2026
- Last update posted
- Aug 25, 2026
2022 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mary and Dick Allen Diabetes Center at Hoag Hospital | Newport Beach | California | 92663 | — |
| Stanford University School of Medicine Center for Academic Medicine | Palo Alto | California | 94304 | — |
| UCSD/ Rady Children's Hospital | San Diego | California | 92123 | — |
| University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM) | Miami | Florida | 33136 | — |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| The Joslin Center | Boston | Massachusetts | 02215 | — |
| Washington University Diabetes Center at Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Hassenfeld Children's Hospital at NYU Langone Health, Pediatric Diabetes Center | New York | New York | 10016 | — |
| Amarillo Medical Specialists | Amarillo | Texas | 79124 | — |
| Diabetes & Glandular Disease Clinic | San Antonio | Texas | 78237 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05018585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05018585 live on ClinicalTrials.gov.