The purpose of this DiaPrevent research study is to see if the investigational Diamyd vaccine shots may help to preserve insulin producing capacity. In this phase III study, two out of three participants receive active vaccine and one out of three receives placebo (shots that look the same but without the active drug).
ABOUT TYPE 1 DIABETES
In type 1 diabetes, the cells that make insulin are under attack by the body´s own
immune system. Studies have shown that people with diabetes who continue to produce
their own insulin have less trouble with low blood sugar and fewer complications
from their diabetes than people who no longer make any insulin.
Study participants need to:
- be between 10 and 20 years old
- be diagnosed with type 1 diabetes
within the past 3 months
- pass screening tests
Study participants will:
- visit the clinic about 8 times during the next
2 ½ years
- receive shots
- have their diabetes closely monitored with the help of their regular doctors or
diabetes care teams
- perform certain tests
WHAT IS DIAMYD VACCINE?
The Diamyd vaccine is an investigational drug aimed at saving a person's ability
to make their own insulin for as long as possible. The vaccine is injected under
the skin. Its active substance is a protein called glutamic acid decarboxylase (GAD).