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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 belowDIAGNODE-3 Trial Timeline
Screening ~ 1 day0 visits
Treatment ~ Varies
Follow Up ~ 22 months0 visits
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~22 months
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 moreDIAGNODE-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)
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any vaccines, including flu and COVID-19, in the last 4 weeks and won't have any for 4 weeks after starting the study drug.I was diagnosed with Type 1 Diabetes less than 6 months ago.My insulin dose has been stable for the last month.I haven't taken any diabetes pills or non-insulin injections in the last 3 months.I do not have any severe inherited blood disorders, except for sickle cell trait or thalassemia minor.I am currently using or have recently used drugs that weaken my immune system, except for short-term steroids.I have the HLA DR3-DQ2 gene.My blood test shows GAD65 antibodies.I am using combined hormonal birth control.I am using a birth control method that stops ovulation.I have had a vasectomy or agree to use two forms of birth control.My medication is taken by mouth.My medication can be given through an injection.My fallopian tubes are surgically blocked.I have had pancreatic surgery, chronic pancreatitis, or other conditions affecting my pancreas.
Research Study Groups:
This trial has the following groups:- Group 1: Diamyd
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 90 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 22 Months after you stop receiving the treatment.
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