Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (141% higher). The trial reports 20 study locations across 11 states.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (141% higher). The listed sponsor is Diamyd Medical AB, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
RECRUITING · Phase 3
-
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
COMPLETED · Phase 3
-
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
COMPLETED · Phase 3
-
Pediatric Diabetics Type 1 Using InsuPatch
COMPLETED · Phase 3
-
Efficacy of Islet After Kidney Transplantation
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.