Sweden's Diamyd Medical has begun a Phase II clinical study of their investigational medication Diamyd. Involved are 70 children and adolescents who have recently succumbed to insulin_dependent, type 1 diabetes. The study is to investigate if these individuals' remaining pancreatic insulin_producing beta cells can be saved through two immunizations of Diamyd. If the "vaccine" works, it could lead to remission of disease, i.e., that the requirement for external insulin injection is minimized or removed entirely.
Data from the company's recent clinical trials with Diamyd indicate vaccination allows protection of the insulin_producing beta cells from destruction by the immune system. This then permits recovery of beta cells and their survival, which should in turn reduce the need for use of external insulin supplementation. Caught in time, dosed with Diamyd, diabetes starts but does not fully develop. This is the hypothesis, and the hope.
The multi-center study is located at sites across Sweden. The study's head is Professor Johnny Ludvigson. Patients included in the study are children and adolescents between 10_18 years of age who have not been diagnosed with diabetes for longer than 18 months. The study is double_blind, random and placebo_controlled.
"This type 1 diabetes study in children and adolescents could represent a breakthrough for antigen_specific treatment of autoimmune diseases. If it is successful, it could completely change the treatment of insulin_dependent diabetes. Instead of daily injections, for the rest of their life, we will instead be able to inject patients just a couple of times, a significant improvement in quality of life for the children," says Diamyd Medical's medical chief Dr. Ann_Sophie Bennet.
Diamyd Medical is also conducting a pivotal Phase II/III clinical trial of type 2 diabetes patients with GAD_specific antibodies (so_called LADA patients). Over 2000 have applied to be part of this study; 160 will be selected. A few of these have already received the first treatment. In an earlier Phase II clinical study of 47 LADA patients, an effective dose of diamyd was identified, and is now used in both the new studies. Professor Carl_David Agardh (Malmo Hospital) reported at the American Diabetes Congress, ADA, in June 2004, that two injections of 20mg Diamyd gave positive results, currently up to two years after treatment, with respect to both insulin production and blood glucose levels.
Remember, this research is ongoing. This medication, while promising, is investigational
-- and it will be years, if ever, before we see it available at the pharmacy.
Stay tuned; we at VOICE OF THE DIABETIC will let you know how the research is
going.