ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05018585

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.

ClinicalTrials.gov public records Last synced May 20, 2026, 8:45 AM EDT

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

Study identification

NCT ID
NCT05018585
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Diamyd Medical AB
Industry
Enrollment
321 participants

Conditions and interventions

Interventions

  • Colecalciferol 2000 IU Dietary Supplement
  • Placebo Biological
  • Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® Biological

Dietary Supplement · Biological

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
Nov 30, 2027
Completion
Nov 30, 2027
Last update posted
Apr 14, 2026

2022 – 2027

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 Apr 14, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05018585 live on ClinicalTrials.gov.

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