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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
- DIETARY_SUPPLEMENT Colecalciferol 2000 IU
Study Locations (20)
Other
- Nemocnice Jihlava, příspěvková organizace — Jihlava
- Institut klinické a experimentální medicíny — Prague
- Fakultní nemocnice v Motole — Prague
- Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z. — Ústí nad Labem
- Liina Viitas OÜ — Pärnu
- North-Estonian Regional Hospital — Tallinn
- Tartu University Hospital — Tartu
California
- Mary and Dick Allen Diabetes Center at Hoag Hospital — Newport Beach
- Stanford University School of Medicine Center for Academic Medicine — Palo Alto
- UCSD/ Rady Children's Hospital — San Diego
Texas
- Amarillo Medical Specialists — Amarillo
- Diabetes & Glandular Disease Clinic — San Antonio
Colorado
- University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes — Aurora
Florida
- Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM) — Miami
Idaho
- Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls
Iowa
- University of Iowa Hospital and Clinics — Iowa City
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05018585
The ClinicalTrials.gov registry entry for NCT05018585 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diamyd Medical AB, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05018585 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05018585 about?
NCT05018585 is a clinical study titled "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". 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 a...
What is the current status of trial NCT05018585?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2022-05-19. Estimated completion is 2027-12.
What conditions does trial NCT05018585 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05018585?
The interventions under investigation include: Placebo (BIOLOGICAL), Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® (BIOLOGICAL), Colecalciferol 2000 IU (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05018585?
This trial is sponsored by Diamyd Medical AB, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05018585 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Idaho, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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