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.

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-2
COORDINATING INVESTIGATOR
Professor Johnny Ludvigsson
  Linköping University, Sweden

A double-blind, placebo-controlled intervention trial, where Diamyd® (GAD-alum) is administered directly into lymph nodes in combination with vitamin D. The trial evaluates the effectiveness of preserving the insulin producing capacity. This trial is conducted in four countries: Sweden, Spain, the Czech Republic and the Netherlands .


DIAGNODE-1
Principal Investigator
Professor Johnny Ludvigsson
  Linköping University, Sweden

An open label intervention trial, where Diamyd® is administered directly into lymph nodes in combination with vitamin D. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity.


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.


OTHER TRIALS WITH DIAMYD®

DiAPREV-IT 2
PRINCIPAL INVESTIGATOR
Dr. Helena Elding Larsson
 Lund University, Sweden

A placebo-controlled prevention trial where Diamyd®, in combination with vitamin D, is administered to children at high risk of developing type 1 diabetes, meaning that they have an ongoing autoimmune process but not yet any clinical symptoms of diabetes. The aim of the trial is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes.


 

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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