DIAMYD® AND REMYGEN® IN CLINICAL TRIALS

 

The efficacy of intralymphatic administration of Diamyd®, an antigen specific immunotherapy aimed at stopping the immune systems attack on the beta cells in autoimmune diabetes, is being confirmed in the Phase IIb trial DIAGNODE-2 and in the Phase I/II trial GADinLADA.

Remygen ®, a regenerative and immunomodulatory therapy aimed at stimulating the regrowth of beta cells in patients with autoimmune diabetes, is being evaluated in the Phase I/II trial ReGenerate-1.

DIAMYD® INTRALYMPHATIC ADMINISTRATION

DIAGNODE-3
COORDINATING INVESTIGATOR
Professor Johnny Ludvigsson
  Linköping University, Sweden

A Phase III, double-blind, placebo-controlled intervention trial, where Diamyd® (GAD-alum) is administered directly into lymph nodes in adolescents and adults with recently diagnosed Type 1 Diabetes, carrying the genetic HLA DR3-DQ2 haplotype. The trial evaluates the effectiveness of preserving the insulin producing capacity. This trial is conducted in six countries: Sweden, Spain, Poland, Germany, the Czech Republic and the Netherlands .


DIAGNODE-B
PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
  Linköping University, Sweden

An open-label investigator-initiated clinical trial where Diamyd® (GAD-alum) is given directly into the lymph node in type 1 diabetes patients carrying the genetically defined haplotype HLA DR3-DQ2 and previously treated with intralymphatic injections of Diamyd® in the DIAGNODE-1 or DIAGNODE-2 trial. The aim of the trial is to evaluate the safety of a booster (fourth/fifth) injection with Diamyd® and the effect on the immune system and the endogenous insulin production.


REMYGEN® AND GABA/DIAMYD®

ReGenerate-1
Principal Investigator
Professor Per-Ola Carlsson
  Uppsala University, Sweden

An open label investigator initiated intervention trial with oral treatment of Remygen®. The aim of the trial is to evaluate the safety of the treatment and the effect on the ability to regenerate insulin-producing beta cells.


 

GOOD SAFETY PROFILE

Diamyd® has been tested in clinical trials with more than 1,000 patients and has presented a good safety profile

 

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