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NCT05018585 · ClinicalTrials.gov registry record · Phase 3
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 3 study of Type 1 Diabetes Mellitus, sponsored by Diamyd Medical AB.
- Active
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT05018585: Active Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Diamyd Medical AB.
NCT05018585 is a Phase 3 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Diamyd Medical AB. The registered enrollment target is 330 participants, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (95% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05018585, a Phase 3 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Diamyd Medical AB.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change from baseline to Month 15 in C-peptide area under the curve (AUC) mean 0-120 min during a 2-hour mixed meal tolerance test (MMTT)
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 |
What the registry record for NCT05018585 still lists
NCT05018585 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (95% higher).
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.
NCT05018585 names 20 study sites across 11 states, led by Other, California, Texas.
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.
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).
Who is sponsoring clinical trial NCT05018585?
This trial is sponsored by Diamyd Medical AB, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05018585's enrollment target sits among peer trials
330 14th of 112 higher than 99 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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