In LADA Diamyd®
has reached Phase II in clinical trials. Various doses of the antigen-based therapy were tested in a randomized double-blind placebo-controlled Phase II study with 47 LADA patients. Depending on study arm, the patients received two injections with a four-week interval of 4, 20, 100 or 500 µg Diamyd®
or placebo. The study was unblinded after six months and the patients were followed for another four and a half years. The study results demonstrate that the best dose of Diamyd®
was 20 µg. A five year follow-up of the participants showed that the risk that a LADA patient will need to begin insulin treatment is significantly reduced after treatment with the antigen-based therapy. Only 14 percent of the patients in the group that received 20 µg of Diamyd®
needed insulin after five years following the initial injection, versus 64 percent in the placebo group. No serious side effects from Diamyd®
were reported during the five-year period. The results were published in the scientific diabetes journal Diabetologia
in April 2009.
Safety data from a Phase II study of Diamyd®
for LADA with 160 LADA patients were collected after 30 months of follow-up. The efficacy data were invalidated in 2007 due to suspected mislabeling of the investigational drug.