A company called Diamyd Therapeutics has begun a phase III research study, the DiaPrevent study, evaluating the effect of a new investigational drug, the Diamyd vaccine, as a possible treatment for recent onset type 1 diabetes. Type 1 diabetes is an autoimmune disease, which means that pancreatic beta cells-the body's insulin-producing cells-are destroyed by the body's own immune system.
Although many people diagnosed with type 1 diabetes manage their disease with insulin therapy, it can still be difficult to control the blood sugar level. To stop or delay the immune system's destruction of beta cells would be of great value in controlling the blood sugar levels. This may also lead to reduced risks for short and long term complications of type 1 diabetes. A previous study in children and adolescents with type 1 diabetes demonstrated that beta cells were protected after receiving Diamyd. The active substance in Diamyd is rhGAD65.
WHAT WILL BE TESTED IN THE STUDY?
This research study involves the use of an investigational drug (the Diamyd vaccine) that may preserve the body's ability to produce and secrete insulin in people with type 1 diabetes. The Diamyd vaccine will be injected into participants subcutaneously (under the skin).
The purpose of this study is to determine whether or not the Diamyd vaccine may help to preserve beta cell function. However, direct positive effects of the Diamyd vaccination cannot be guaranteed. In this phase III study, two out of three participants receive active vaccine and one receives placebo. A placebo is a substance that looks like the vaccine but has no active drug.
WHO CAN PARTICIPATE IN THE STUDY?
The DiaPrevent diabetes research study is now closed for enrollment. This study will include participants who are between 10 and 20 years of age and diagnosed with type 1 diabetes within the last 3 months. The participants will be asked to attend 8 visits to a doctor participating in the study, for routine examinations and for taking blood and urine samples. Also, at 6 of these visits, a test will be performed to evaluate the body's ability to produce insulin. The total duration of the study is about 2 ½ years.
WHAT ARE THE POTENTIAL BENEFITS?
If the destruction of the insulin producing cells could be slowed or stopped, the body would continue to make some of its own insulin. This would likely result in better control of blood sugar levels, and fewer long term complications. There is no guarantee that this will happen. You may not benefit from this study.
WHAT ARE THE POTENTIAL RISKS?
Like any investigational drug, the Diamyd vaccine may have unknown risks. The study doctor will discuss potential risks associated with the vaccine.