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DIAGNODE-3 study for recently diagnosed type I diabetes (DIAGNODE-3 Trial)

Phase 3
Recruiting
Led By Johnny Ludvigsson, Professor
Research Sponsored by Diamyd Medical AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you 12 to 29 years of age?
Have you been diagnosed with type 1 diabetes within the last 6 months?
Timeline
Screening 1 day
Treatment Varies
Follow Up 22 months
Awards & highlights

DIAGNODE-3 Trial Summary

The DIAGNODE-3 study is testing an investigational drug called Diamyd (rhGAD65) to see if it is able to preserve the body's own insulin-producing capacity by halting or delaying the autoimmune attack on the beta cells. Sustained beta cell function is associated with better metabolic control and a lower risk of low blood sugars and chronic complications..

Who is the study for?
We are recruiting adolescents and adults recently diagnosed with type I diabetes who carry the the genetic human leukocyte antigen (HLA) Dr3-DQ2 haplotype. A haplotype is a group of genes, often inherited together and part of your genetic makeup, or DNA. Participants will be initially screened to see if they carry this HLA genotype and thereby qualify for the study.Check my eligibility
What is being tested?
The active ingredient in Diamyd is the human protein glutamic acid decarboxylase (GAD). Treatment with Diamyd is thought to intervene in the autoimmune attack and thereby preserve the body's ability to produce insulin.See study design
What are the potential side effects?
Diamyd has been studied for over 20 years in 15 completed and ongoing clinical trials with over 1500 patients. All studies have indicated a favorable safety profile for Diamyd.

DIAGNODE-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

DIAGNODE-3 Trial Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~22 months
This trial's timeline: 1 day for screening, Varies for treatment, and 22 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin A1c (HbA1c).
Change in stimulated C-peptide during a MMTT
Secondary outcome measures
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) between baseline and Month 24.
Diabetic Ketoacidosis
Number of episodes per patient of severe hypoglycemia between baseline and Month 24.
+1 more

DIAGNODE-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DiamydExperimental Treatment2 Interventions
Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
Group II: PlaceboPlacebo Group2 Interventions
Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)

Find a Location

Who is running the clinical trial?

Diamyd Medical ABLead Sponsor
8 Previous Clinical Trials
272 Total Patients Enrolled
Johnny Ludvigsson, ProfessorPrincipal InvestigatorCrown Princess Victoria Children´s Hospital and Linköping University
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Placebo for recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05018585 — Phase 3
Type 1 Diabetes Research Study Groups: Diamyd, Placebo
Type 1 Diabetes Clinical Trial 2023: Placebo for recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® Highlights & Side Effects. Trial Name: NCT05018585 — Phase 3
Placebo for recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel® (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018585 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What should participants expect?

"The study will last about 26 months and requires up to 11 study visits as well as follow-up phone calls."

Answered by AI

Does this investigation involve any participants over sixty years of age?

"No. This study is recruiting people who are between 12 and 29 years of age."

Answered by AI

Has the Diamyd medication been given the go-ahead by the FDA?

"Diamyd has recently received FDA fast-track status, meaning it will be approved faster by the FDA."

Answered by AI

Are there any other research studies related to Diamyd that have been completed?

"Diamyd has been studied for over 20 years in 15 completed and ongoing clinical trials with over 1500 patients. All studies have indicated a favorable safety profile for Diamyd."

Answered by AI

What is the geographic scope of this clinical trial?

"The DIAGNODE-3 trial is recruiting participants at 15 sites across the United States."

Answered by AI

What will participants who qualify for the study receive?

"Participants who qualify for the study will receive the study drug or placebo (an inactive substance) given by injection (2 out of 3 will receive Diamyd and 1 our of 3 will receive a placebo, so there is 67% chance of receiving the study drug)"

Answered by AI

What are other benefits of participating?

"Participants who qualify for the study will receive study-related medical tests, health monitoring (including regular vitamin d levels and supplementation, if necessary), and follow-up care throughout the study. They will also receive diabetes education and an opportunity to make a difference in important type 1 diabetes precision medicine research. Compensation will be provided for study-related travel."

Answered by AI

What is type 1 diabetes?

"Type 1 diabetes (T1D) is an autoimmune disorder in which the immune system attacks the insulin-producing beta cells in the pancreas. By the time an individual is diagnosed, 70% to 90% of one's insulin-producing capacity has been lost, and one must rely on insulin administered in the form of shots, pens, or pumps to replace this essential lifesaving hormone."

Answered by AI

What is the treatment protocol?

"All participants will be randomly assigned (by chance) to receive 3 injections into a lymph node of the study drug or placebo given over 2 months. Neither you/your child nor the study doctor will know which group you are in."

Answered by AI

Who else is applying?

What site did they apply to?
Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Diamyd Administered Into Lymph Nodes in Individuals Recently Diagnosed With Type 1 Diabetes, Carrying the HLA DR3-DQ2 Haplotype
2022. "Diamyd Administered Into Lymph Nodes in Individuals Recently Diagnosed With Type 1 Diabetes, Carrying the HLA DR3-DQ2 Haplotype". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05018585.
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~153 spots leftby Dec 2025
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