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-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 with oral supplements of 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 .


GADinLADA
Sponsor’s representative
Ingrid K Hals, PhD (Norway)
Anneli Björklund, MD, PhD (Sweden)

  Norway and Sweden

Norway: Norwegian University of Science and Technology in Trondheim (NTNU), in cooperation with St. Olav’s University Hospital, Trondheim.

Sweden: Academic Specialist Center, Center for Diabetes, Karolinska Institute, Karolinska University Hospital, Stockholm.

An open label investigator initiated clinical trial, where Diamyd®(GAD-alum) is administered directly into lymph nodes with oral supplements of vitamin D. The purpose of the trial is to evaluate the safety of intralymphatic treatment with Diamyd® in LADA patients and the effectiveness of preserving the insulin producing capacity. The trial is conducted in Norway and Sweden.


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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