What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes that involve immune modulation, such as the GAD vaccine (Diamyd), include therapies like teplizumab and otelixizumab. Known side effects of these treatments can include gastrointestinal symptoms, headache, and hypersensitivity reactions. Additionally, immune modulation therapies may carry risks of infections due to their impact on the immune system. For example, teplizumab has been associated with rash and transient lymphopenia, while otelixizumab can cause flu-like symptoms and transient Epstein-Barr virus reactivation.

What prior FDA approvals exist?

The FDA has approved several immune-modulating therapies for Type 1 Diabetes, although none specifically involve the GAD vaccine like Diamyd. Teplizumab, a monoclonal anti-CD3 antibody, has shown promise in delaying the onset of Type 1 Diabetes in high-risk individuals by modulating the immune response. Another similar drug, Otelixizumab, also a monoclonal anti-CD3 antibody, has demonstrated efficacy in preserving beta-cell function in newly diagnosed patients. These treatments aim to alter the immune system's attack on pancreatic beta cells, similar to the immune modulation approach of the GAD vaccine in the Diamyd trial.

What other types of research exist?

Promising novel alternatives to Diamyd for Type 1 Diabetes patients include: 1) Anti-idiotypic antibody specific to GAD65 autoantibody, which has shown potential in preventing T1D in NOD mice by modulating the immune response. 2) Gene-gun biolistic immunization encoding glutamic acid decarboxylase (GAD), which is being studied for its potential to modulate autoimmune responses in T1D. 3) Intralymphatic administration of GAD-alum, which is being evaluated in clinical trials for its efficacy in preserving beta-cell function. These alternatives focus on immune modulation and preservation of beta-cell function, similar to Diamyd.

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Placebo

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

Pivotal Trial

Summary

This trial tests if using Diamyd and Vitamin D can help young people and adults with Type 1 Diabetes. The goal is to help their bodies keep making insulin for longer. High dose vitamin D and omega 3 have shown promise in prolonging remission in Type 1 Diabetes.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 1 day0 visits

Treatment ~ Varies

Follow Up ~ 22 months0 visits

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in hemoglobin A1c (HbA1c).

Change in stimulated C-peptide during a MMTT

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1D) include insulin therapy and immune modulation therapies. Insulin therapy involves administering insulin to manage blood glucose levels, as T1D patients have insufficient insulin production due to autoimmune destruction of pancreatic beta cells. Immune modulation therapies, such as the GAD vaccine studied in the Diamyd trial, aim to preserve beta-cell function by modulating the immune system to prevent further autoimmune attacks. This is crucial for T1D patients as it can potentially reduce the need for exogenous insulin, improve metabolic control, and delay disease progression, thereby enhancing the quality of life and reducing long-term complications.

New Insights into Immunotherapy Strategies for Treating Autoimmune Diabetes.The role of immunomodulation therapy in autoimmune diabetes.