The diabetes vaccine trial DIAGNODE-2 is ongoing
but fully recruited

 

Patient meeting with clinical study investigator
DIAGNODE-2
 ClinicalTrials.gov
COORDINATING INVESTIGATOR
Professor Johnny Ludvigsson
  Linköpings universitet, Sweden
 

A double-blind, placebo-controlled intervention trial, where Diamyd® (GAD-alum) is administrated directly into lymph nodes in combination with vitamin D. The trial evaluate the effectiveness of preserving the insulin producing capacity.

About the DIAGNODE-2 trial

During a medical examination, a blood sample will be taken to detect the presence of certain antibodies, and if there is any residual insulin production to rescue. If the sample values match the treatment criteria, treatment with oral administration of vitamin D or placebo begins. After one month, an injection of Diamyd® or placebo is administered to a lymph node in the groin by an experienced specialist. The injection sensation is comparable to venous blood draw in arm. A total of three injections are given, one month apart, and vitamin D is taken during a four month period. During the trial, regular visits to the clinic are scheduled where a doctor check the participants physical health.

Half of patients participating in the trial receive the study drug (Diamyd®) and the other half receive placebo, an injection without the active treatment. The treatment is randomly determined by a computer. Neither the study participant nor the study doctor knows which treatment is given. Participation is voluntary, free of charge and the participant may discontinue participation at any time.

The clinical trial investigate the treatment effect on residual insulin production

Participants are given vaccination with Diamyd® or placebo into a lymph node

In newly diagnosed type 1 diabetes, residual insulin producing capacity may be possible to preserve

The trial sponsor Diamyd Medical have obtained approval from the national competent authorities responsible for human medicine and the Ethics Committees for conducting the Phase II trial DIAGNODE-2 in the participating countries. The patient recruitment information is approved by the national Ethics Committees.

EudraCT Number: 2017-001861-25
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