DIAMYD® AND REMYGEN® IN CLINCAL 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 product aimed at stimulating the regrowth of beta cells in patients with diabetes, will be evaluated in patients for the first time in 2018. In addition, Diamyd® is being evaluated in different combinations in ongoing investigator-initiated trials.

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 three countries: Sweden, Spain and the Czech Republic.


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. The trial starts in 2018.


GABA/DIAMYD®
Principal Investigator
Professor Kenneth McCormick
  University of Alabama at Birmingham, USA

A placebo-controlled intervention trial where Diamyd® is combined with GABA. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin.


OTHER TRIALS WITH DIAMYD®

EDCR IIa
PRINCIPAL INVESTIGATOR
Professor Johnny Ludvigsson
 Linköping University, Sweden

An open label intervention trial where Diamyd® is combined with etanercept and 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 patient’s insulin producing capacity.


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 administered to more than 1,000 patients in clinical trials and has presented a good safety profile